title: Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)

text:
               9.4.2005

               EN

               Official Journal of the European Union

               L 91/13

         COMMISSION DIRECTIVE 2005/28/EC
   of 8 April 2005
   laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (1), and in particular Article 1(3), Article 13(1) and Article 15(5) thereof,
   Whereas:

               (1)

               Directive 2001/20/EC requires the adoption of principles of good clinical practice and detailed guidelines in line with those principles, minimum requirements for authorisation of the manufacture or importation of investigational medicinal products, and detailed guidelines on the documentation relating to clinical trials to verify their compliance with Directive 2001/20/EC.

               (2)

               The principles and guidelines for good clinical practice should be such as to ensure that the conduct of clinical trials on investigational medicinal products, as defined in Article 2(d) of Directive 2001/20/EC, is founded in the protection of human rights and the dignity of the human being.

               (3)

               Manufacturing requirements to be applied to investigational medicinal products are provided for by Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (2). Title IV of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3) contains the provisions applied for the authorisation for the manufacture of medicinal products as part of the requirements needed for the application for a marketing authorisation. Article 3(3) of that Directive establishes that these requirements are not applicable for medicinal products intended for research and development trials. It is therefore necessary to lay down minimal requirements regarding applications for and management of authorisations to manufacture or import investigational medicinal products, as well as for the granting and the content of the authorisations, in order to guarantee the quality of the investigational medicinal product used in the clinical trial.

               (4)

               With regard to the protection of trial subjects and to ensure that unnecessary clinical trials will not be conducted, it is important to define principles and detailed guidelines of good clinical practice whilst allowing the results of the trials to be documented for use in a later phase.

               (5)

               To ensure that all experts and individuals involved in the design, initiation, conduct and recording of clinical trials apply the same standards of good clinical practice, principles and detailed guidelines of good clinical practice have to be defined.

               (6)

               Provisions for the functioning of the Ethics Committees should be established in each Member State on the basis of common detailed guidelines, in order to ensure the protection of the trial subject while at the same time allowing a harmonised application in the different Member States of the procedures to be used by Ethics Committees.

               (7)

               To secure the compliance of clinical trials with the provisions on good clinical practice, it is necessary that inspectors ensure the practical effectiveness of such provisions. It is essential therefore to provide detailed guidelines on the minimum standards for the qualification of inspectors, in particular as regards their education and training. For the same reason, detailed guidelines on inspection procedures, in particular on the cooperation of the various agencies, and the follow-up to the inspections, should be laid down.

               (8)

               The International Conference on Harmonisation (ICH) reached a consensus in 1995 to provide a harmonised approach for Good Clinical Practice. The consensus paper should be taken into account as agreed upon by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, hereinafter ‘the Agency’, and published by the Agency.

               (9)

               It is necessary that sponsors, investigators and other participants take into account the scientific guidelines relating to the quality, safety and efficacy of medicinal products for human use, as agreed upon by the CHMP and published by the Agency, as well as the other pharmaceutical Community guidelines published by the Commission in the different volumes of The rules governing medicinal products in the European Community.

               (10)

               In conducting clinical trials on investigational medicinal products for human use, the safety and the protection of the rights of trial subjects should be ensured. The detailed rules adopted by Member States pursuant to Article 3(1) of Directive 2001/20/EC, to protect from abuse individuals who are incapable of giving their informed consent should also cover individuals temporarily incapable of giving their informed consent, as in emergency situations.

               (11)

               Non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry may be of great benefit to the patients concerned. Directive 2001/20/EC recognises the specificity of these non-commercial clinical trials. In particular, when trials are conducted with authorised medicinal products and on patients with the same characteristics as those covered by the authorised indication, requirements already fulfilled by these authorised medicinal products, as far as manufacturing or importation are concerned, should be taken into consideration. However, it could also be necessary, due to the specific conditions under which non-commercial trials are conducted, that Member States foresee specific modalities to be applied to these trials not only when conducted with authorised medicinal products and on patients with the same characteristics, in order to comply with the principles imposed by this Directive, in particular as far as the manufacturing or import requirements for authorisation and the documentation to be submitted and archived for the trial master file are concerned. The conditions under which the non-commercial research is conducted by public researchers and the places where this research takes place, make the application of certain of the details of good clinical practice unnecessary or guaranteed by other means. Member States will ensure in these cases, when providing for specific modalities, that the objectives of the protection of the rights of patients who participate in the trial, as well as, in general, the correct application of the good clinical practice principles, are achieved. The Commission will prepare a draft with guidance in this respect.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER 1
   SUBJECT-MATTER
   Article 1
   1.   This Directive lays down the following provisions to be applied to investigational medicinal products for human use:

               (a)

               the principles of good clinical practice and detailed guidelines in line with those principles, as referred to in Article 1(3) of Directive 2001/20/EC, for the design, conduct and reporting of clinical trials on human subjects involving such products;

               (b)

               the requirements for authorisation of the manufacture or importation of such products, as provided for in Article 13(1) of Directive 2001/20/EC;

               (c)

               the detailed guidelines, provided for in Article 15(5) of Directive 2001/20/EC, on the documentation relating to clinical trials, archiving, qualifications of inspectors and inspection procedures.

         2.   When applying the principles, detailed guidelines and requirements referred to in paragraph 1, Member States shall take into account the technical implementing modalities provided for in the detailed guidance published by the Commission in The Rules governing medicinal products in the European Union.
   3.   When applying the principles, detailed guidelines and requirements referred to in paragraph 1 to non-commercial clinical trials conducted by researchers without the participation of the pharmaceutical industry, Member States may introduce specific modalities in order to take into account the specificity of these trials as far as Chapters 3 and 4 are concerned.
   4.   Member States may take into account the special position of trials whose planning does not require particular manufacturing or packaging processes, carried out with medicinal products with marketing authorisations within the meaning of Directive 2001/83/EC, manufactured or imported in accordance with the same Directive and conducted on patients with the same characteristics as those covered by the indication specified in the marketing authorisation.
   Labelling of investigational medicinal products intended for trials of that nature may be subject to simplified provisions laid down in the good manufacturing practice guidelines on investigational medicinal products.
   Member States shall inform the Commission as well as the other Member States of any specific modalities implemented in accordance with this paragraph. These modalities will be published by the Commission.
   CHAPTER 2
   GOOD CLINICAL PRACTICE FOR THE DESIGN, CONDUCT, RECORDING AND REPORTING OF CLINICAL TRIALS
   SECTION 1
   GOOD CLINICAL PRACTICE
   Article 2
   1.   The rights, safety and well being of the trial subjects shall prevail over the interests of science and society.
   2.   Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his tasks.
   3.   Clinical trials shall be scientifically sound and guided by ethical principles in all their aspects.
   4.   The necessary procedures to secure the quality of every aspect of the trials shall be complied with.
   Article 3
   The available non-clinical and clinical information on an investigational medicinal product shall be adequate to support the proposed clinical trial.
   Clinical trials shall be conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996).
   Article 4
   The protocol referred to in point (h) of Article 2 of Directive 2001/20/EC shall provide for the definition of inclusion and exclusion of subjects participating in a clinical trial, monitoring and publication policy.
   The investigator and sponsor shall consider all relevant guidance with respect to commencing and conducting a clinical trial.
   Article 5
   All clinical trial information shall be recorded, handled, and stored in such a way that it can be accurately reported, interpreted and verified, while the confidentiality of records of the trial subjects remains protected.
   SECTION 2
   THE ETHICS COMMITTEE
   Article 6
   1.   Each Ethics Committee established under Article 6(1) of Directive 2001/20/EC shall adopt the relevant rules of procedure necessary to implement the requirements set out in that Directive and, in particular, in Articles 6 and 7 thereof.
   2.   The Ethics Committees shall, in every case, retain the essential documents relating to a clinical trial, as referred to in Article 15(5) of Directive 2001/20/EC, for at least three years after completion of that trial. They shall retain the documents for a longer period, where so required under other applicable requirements.
   3.   Communication of information between the Ethics Committees and the competent authorities of the Member States shall be ensured through appropriate and efficient systems.
   SECTION 3
   THE SPONSORS
   Article 7
   1.   A sponsor may delegate any or all of his trial-related functions to an individual, a company, an institution or an organisation.
   However, in such cases, the sponsor shall remain responsible for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC as well as this Directive.
   2.   The investigator and the sponsor may be the same person.
   SECTION 4
   INVESTIGATOR’S BROCHURE
   Article 8
   1.   The information in the investigator’s brochure, referred to in Article 2(g) of Directive 2001/20/EC, shall be presented in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial.
   The first subparagraph shall apply also to any update of the investigator’s brochure.
   2.   If the investigational medicinal product has a marketing authorisation, the Summary of Product Characteristics may be used instead of the investigator’s brochure.
   3.   The investigator’s brochure shall be validated and updated by the sponsor at least once a year.
   CHAPTER 3
   MANUFACTURING OR IMPORT AUTHORISATION
   Article 9
   1.   Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall be required for both total and partial manufacture of investigational medicinal products, and for the various processes of dividing up, packaging or presentation. Such authorisation shall be required even if the products manufactured are intended for export.
   Authorisation shall also be required for imports from third countries into a Member State.
   2.   Authorisation, as provided for in Article 13(1) of Directive 2001/20/EC, shall not be required for reconstitution prior to use or packaging, where those processes are carried out in hospitals, health centres or clinics, by pharmacists or other persons legally authorised in the Member States to carry out such processes and if the investigational medicinal products are intended to be used exclusively in those institutions.
   Article 10
   1.   In order to obtain the authorisation the applicant must meet at least the following requirements:

               (a)

               specify in his application the types of medicinal products and pharmaceutical forms to be manufactured or imported;

               (b)

               specify in his application the relevant manufacture or import operations;

               (c)

               specify in his application, where relevant as in the case of viral or non-conventional agents’ inactivation, the manufacturing process;

               (d)

               specify in his application the place where the products are to be manufactured or have at his disposal, for their manufacture or importation, suitable and sufficient premises, technical equipment and control facilities complying with the requirements of Directive 2003/94/EC as regards the manufacture, control and storage of the products;

               (e)

               have permanently and continuously at his disposal the services of at least one qualified person as referred to in Article 13(2) of Directive 2001/20/EC.

         For the purposes of point (a) of the first subparagraph, ‘types of medicinal products’ include blood products, immunological products, cell therapy products, gene therapy products, biotechnology products, human or animal extracted products, herbal products, homeopathic products, radiopharmaceutical products and products containing chemical active ingredients.
   2.   The applicant shall provide with his application documentary evidence that he complies with paragraph 1.
   Article 11
   1.   The competent authority shall issue the authorisation only after verifying the accuracy of the particulars provided by the applicant pursuant to Article 10 by the means of an inquiry carried out by its agents.
   2.   Member States shall take all appropriate measures to ensure that the procedure for granting an authorisation is completed within 90 days of the day on which the competent authority receives a valid application.
   3.   The competent authority of the Member State may require from the applicant further information concerning the particulars supplied pursuant to Article 10(1), including in particular information concerning the qualified person at the disposal of the applicant in accordance with point (e) of Article 10(1).
   Where the competent authority concerned exercises that right, the application of the time-limits laid down in paragraph 2 shall be suspended until the additional data required have been supplied.
   Article 12
   1.   In order to ensure that the requirements laid down in Article 10 are complied with, authorisation may be made conditional on the carrying out of certain obligations imposed either when authorisation is granted or at a later date.
   2.   An authorisation shall apply only to the premises specified in the application and to the types of medicinal products and pharmaceutical forms specified in that application pursuant to point (a) of Article 10(1).
   Article 13
   The holder of the authorisation shall at least comply with the following requirements:

               (a)

               to have at his disposal the services of staff that comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;

               (b)

               to dispose of the investigational/authorised medicinal products only in accordance with the legislation of the Member State concerned;

               (c)

               to give prior notice to the competent authority of any changes he may wish to make to any of the particulars supplied pursuant Article 10(1) and, in particular, to inform the competent authority immediately if the qualified person referred to in Article 13(2) of Directive 2001/20/EC is replaced unexpectedly;

               (d)

               to allow agents of the competent authority of the Member State concerned access to his premises at any time;

               (e)

               to enable the qualified person referred to in Article 13(2) of Directive 2001/20/EC to carry out his duties, for example by placing at his disposal all the necessary facilities;

               (f)

               to comply with the principles and guidelines for good manufacturing practice for medicinal products as laid down by Community law.

         Detailed guidelines in line with the principles referred to in point (f) of the first paragraph will be published by the Commission and revised where necessary to take account of technical and scientific progress.
   Article 14
   If the holder of the authorisation requests a change in any of the particulars referred to in points (a) to (e) of Article 10(1), the time taken for the procedure relating to the request shall not exceed 30 days. In exceptional cases, this period of time may be extended to 90 days.
   Article 15
   The competent authority shall suspend or revoke the authorisation, as a whole or in part, if the holder of the authorisation fails at any time to comply with the relevant requirements.
   CHAPTER 4
   THE TRIAL MASTER FILE AND ARCHIVING
   Article 16
   The documentation referred to Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated. Those documents shall show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements and, in particular, with Annex I to Directive 2001/83/EC.
   The trial master file shall provide the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority.
   The content of the essential documents shall be in accordance with the specificities of each phase of the clinical trial.
   The Commission shall publish additional guidance in order to specify the content of these documents.
   Article 17
   The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.
   They shall retain the documents for a longer period, where so required by other applicable requirements or by an agreement between the sponsor and the investigator.
   Essential documents shall be archived in a way that ensures that they are readily available, upon request, to the competent authorities.
   The medical files of trial subjects shall be retained in accordance with national legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.
   Article 18
   Any transfer of ownership of the data or of documents shall be documented. The new owner shall assume responsibility for data retention and archiving in accordance with Article 17.
   Article 19
   The sponsor shall appoint individuals within its organisation who are responsible for archives.
   Access to archives shall be restricted to the named individuals responsible for the archives.
   Article 20
   The media used to store essential documents shall be such that those documents remain complete and legible throughout the required period of retention and can be made available to the competent authorities upon request.
   Any alteration to records shall be traceable.
   CHAPTER 5
   INSPECTORS
   Article 21
   1.   The inspectors, appointed by the Member States pursuant to Article 15(1) of Directive 2001/20/EC, shall be made aware of and maintain confidentiality whenever they gain access to confidential information as a result of good clinical practice inspections in accordance with applicable Community requirements, national laws or international agreements.
   2.   Member States shall ensure that inspectors have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other relevant fields.
   3.   Member States shall ensure that inspectors receive appropriate training, that their training needs are assessed regularly and that appropriate action is taken to maintain and improve their skills.
   Member States shall also ensure that the inspectors have knowledge of the principles and processes that apply to the development of medicinal products and clinical research. Inspectors shall also have knowledge of applicable Community and national legislation and guidelines applicable to the conduct of clinical trials and the granting of marketing authorisations.
   The inspectors shall be familiar with the procedures and systems for recording clinical data, and with the organisation and regulation of the healthcare system in the relevant Member States and, where appropriate, in third countries.
   4.   Member States shall maintain up-to-date records of the qualifications, training and experience of each inspector.
   5.   Each inspector shall be provided with a document setting out standard operating procedures and giving details of the duties, responsibilities and ongoing training requirements. Those procedures shall be maintained up to date.
   6.   Inspectors shall be provided with suitable means of identification.
   7.   Each inspector shall sign a statement declaring any financial or other links to the parties to be inspected. That statement shall be taken into consideration when inspectors are to be assigned to a specific inspection.
   Article 22
   In order to ensure the presence of skills necessary for specific inspections, Member State may appoint teams of inspectors and experts with appropriate qualifications and experience to fulfil collectively the requirements necessary for conducting the inspection.
   CHAPTER 6
   INSPECTION PROCEDURES
   Article 23
   1.   Good clinical practice inspections may take place on any of the following occasions:

               (a)

               before, during or after the conduct of clinical trials;

               (b)

               as part of the verification of applications for marketing authorisation;

               (c)

               as a follow-up to the granting of authorisation.

         2.   In accordance with Article 15(1) and (2) of Directive 2001/20/EC, inspections may be requested and coordinated by the European Medicines Agency within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (4), especially in connection with clinical trials relating to applications through the procedure established by this Regulation.
   3.   Inspections shall be conducted in accordance with the inspection guidance documents developed to support the mutual recognition of inspection findings within the Community.
   4.   Improvement and harmonisation of inspection guidance shall be achieved by the Member States, in collaboration with the Commission and the Agency, through joint inspections, agreed processes and procedures and sharing of experience and training.
   Article 24
   Member States shall make publicly available within their territories the documents relating to the adoption of good clinical practice principles.
   They shall establish the legal and administrative framework within which their good clinical practice inspections operate, with definition of the powers of inspectors for entry into clinical trial sites and access to data. In so doing they shall ensure that, on request and where appropriate, inspectors of the competent authority of the other Member States also have access to the clinical trial sites and data.
   Article 25
   Member States shall provide for sufficient resources and shall in particular appoint an adequate number of inspectors to ensure effective verification of compliance with good clinical practice.
   Article 26
   Member States shall establish the relevant procedures for verification of good clinical practice compliance.
   The procedures shall include the modalities for examining both the study management procedures and the conditions under which clinical trials are planned, performed, monitored and recorded, as well as follow-up measures.
   Article 27
   Member States shall establish the relevant procedures for the following:

               (a)

               appointing experts for accompanying inspectors in case of need;

               (b)

               requesting inspections/assistance from other Member States, in line with Article 15(1) of Directive 2001/20/EC and for cooperating in inspections in another Member State;

               (c)

               arranging inspections in third countries.

         Article 28
   Member States shall maintain records of national and, if applicable, international inspections including the good clinical practice compliance status, and of their follow-up.
   Article 29
   1.   In order to harmonise the conduct of inspections by the competent authorities of the different Member States, guidance documents containing the common provisions on the conduct of those inspections shall be published by the Commission after consultation with the Member States.
   2.   Member States shall ensure that national inspection procedures are in compliance with the guidance documents referred in paragraph 1.
   3.   The guidance documents referred to in paragraph 1 may be updated regularly according to scientific and technical development.
   Article 30
   1.   Member States shall lay down all necessary rules to ensure that confidentiality is respected by inspectors and other experts. With regard to personal data, the requirements of Directive 95/46/EC of the European Parliament and of the Council (5) shall be respected.
   2.   Inspection reports shall be made available by the Member States only to the recipients referred to in Article 15(2) of Directive 2001/20/EC, in accordance with national regulations of the Member States and subject to any arrangements concluded between the Community and third countries.
   CHAPTER 7
   FINAL PROVISIONS
   Article 31
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 29 January 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt these provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 32
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 33
   This Directive is addressed to the Member States.

      Done at Brussels, 8 April 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 121, 1.5.2001, p. 34.

      (2)  OJ L 262, 14.10.2003, p. 22.

      (3)  OJ L 311, 28.11.2003, p. 67. Directive as last amended by Directive 2004/27/EC (OJ L 136, 30.4.2004, p. 34).

      (4)  OJ L 136, 30.4.2004, p. 1.

      (5)  OJ L 281, 23.11.1995, p. 31.


Avis juridique important

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31997L0038

Commission Directive 97/38/EC of 20 June 1997 amending Annex C to Council Directive 92/51/EEC on a second general system for the recognition of professional education and training to supplement Council Directive 89/48/EEC (Text with EEA relevance)

Official Journal L 184 , 12/07/1997 P. 0031 - 0032

COMMISSION DIRECTIVE 97/38/EC of 20 June 1997 amending Annex C to Council Directive 92/51/EEC on a second general system for the recognition of professional education and training to supplement Council Directive 89/48/EEC (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC (1), as last amended by Commission Directive 95/43/EC (2), and in particular Article 15 thereof,Whereas the government of the United Kingdom has made a reasoned request to remove three of its training courses from Annex C to the Directive;Whereas the United Kingdom has altered its education and training course for medical laboratory scientific officer, with the result that this course now requires three years of higher education and thus comes under Council Directive 89/48/EEC (3); whereas, accordingly, the course of education and training for the profession of medical laboratory scientific officer should no longer be included in Annex C since holders of qualifications obtained under the former regulation and which are covered by Directive 92/51/EEC could, by virtue of Article 1 (a) of Directive 89/48/EEC, apply to be treated in the same way;Whereas the profession of prosthetist is currently not regulated in the United Kingdom;Whereas the profession of probation officer is no longer regulated in the United Kingdom;Whereas the measures provided for by the present directive are in conformity with the opinion given by the Committee established by Article 15 of Council Directive 92/51/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1 Annex C to Directive 92/51/EEC is hereby amended as shown in the Annex to this Directive.Article 2 1. Member States shall adopt the laws, regulations and administrative provisions necessary for them to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof.When Member States adopt these measures, the latter shall include a reference to this Directive or be accompanied by such reference at the time of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.Article 3 This Directive is addressed to the Member States.Article 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Done at Brussels, 20 June 1997.For the CommissionMario MONTIMember of the Commission(1) OJ No L 209, 24. 7. 1992, p. 25.(2) OJ No L 184, 3. 8. 1995, p. 21.(3) OJ No L 19, 24. 1. 1989, p. 16.ANNEX Annex C of Directive 92/51/EEC is amended as follows:Under '5. United Kingdom courses accredited as National Vocational Qualifications or Scottish Vocational Qualifications` the following indents are deleted:'- medical laboratory scientific officer,- probation officer,- prosthetist,`.


Avis juridique important

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31999L0042

Directive 1999/42/EC of the European Parliament and of the Council of 7 June 1999 establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualifications

Official Journal L 201 , 31/07/1999 P. 0077 - 0093

DIRECTIVE 1999/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCILof 7 June 1999establishing a mechanism for the recognition of qualifications in respect of the professional activities covered by the Directives on liberalisation and transitional measures and supplementing the general systems for the recognition of qualificationsTHE EUROPEAN PARLIAMENT ANDTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Articles 40 and 47(1), the first and third sentences of Article 47(2), and Article 55 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion delivered by the Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3) and in the light of the joint text adopted on 22 April 1999,(1) Whereas, under the Treaty, all discriminatory treatment on grounds of nationality with regard to establishment and provision of services is prohibited as from the end of the transitional period; whereas, therefore, certain provisions of the Directives applying in this area have become redundant for the purposes of applying the rule of national treatment, since that rule is enshrined in the Treaty itself and has direct effect;(2) Whereas, however, certain of the Directives' provisions designed to facilitate the effective exercise of the right of establishment and freedom to provide services should be retained, particularly where they usefully prescribe how obligations under the Treaty are to be discharged;(3) Whereas, in order to facilitate the exercise of freedom of establishment and freedom to provide services in respect of a number of activities, Directives introducing transitional measures have been adopted pending mutual recognition of qualifications; whereas those Directives accept the fact that the activity in question has been pursued for a reasonable and sufficiently recent period of time in the Member State from which the national comes as a sufficient qualification for taking up the activities in question in Member States which have rules governing the taking up of such activities;(4) Whereas the main provisions of the said Directives should be replaced in line with the conclusions of the European Council held in Edinburgh on 11 and 12 December 1992 regarding subsidiarity, simplification of Community legislation and, in particular, the reconsideration by the Commission of the relatively old directives dealing with professional qualifications; whereas the Directives in question should therefore be repealed;(5) Whereas Council Directive 89/48/EEC of 21 December 1988 on a general system for the recognition of higher-education diplomas awarded on completion of professional education and training of at least three years' duration(4) and Council Directive 92/51/EEC of 18 June 1992 on a second general system for the recognition of professional education and training to supplement Directive 89/48/EEC(5) do not apply to certain professional activities covered by the Directives applying to this subject-matter (Part One of Annex A to this Directive); whereas recognition machinery in respect of qualifications should, therefore, be introduced for those professional activities not covered by Directives 89/48/EEC and 92/51/EEC; whereas the professional activities listed in Part Two of Annex A to this Directive fall for the most part within the scope of Directive 92/51/EEC as far as the recognition of diplomas is concerned;(6) Whereas a proposal has been transmitted to the Council with a view to amending Directives 89/48/EEC and 92/51/EEC in respect of the proof of financial standing and the proof of an insurance against financial risks that a host Member State may require of the beneficiary; whereas the Council intends to deal with this proposal at a later stage;(7) Whereas a proposal has been transmitted to the Council with a view to facilitating the free movement of specialised nurses who do not have any of the qualifications listed in Article 3 of Directive 77/452/EEC(6); whereas the Council intends to deal with this proposal at a later stage;(8) Whereas this Directive should require regular reports to be drawn up on its implementation;(9) Whereas this Directive without prejudice to the application of Articles 39(4) and 45 of the Treaty,HAVE ADOPTED THIS DIRECTIVE:TITLE IScopeArticle 11. Member States shall adopt the measures defined in this Directive in respect of establishment or provision of services in their territories by natural persons and companies or firms covered by Title I of the General Programmes for the abolition of restrictions on freedom to supply services(7) and on freedom of establishment(8) (hereinafter called "beneficiaries") who wish to pursue the activities listed in Annex A.2. This Directive shall apply to the activities listed in Annex A which nationals of Member States wish to pursue in a host Member State in a self-employed or employed capacity.Article 2Member States in which the taking-up or pursuit of any activity referred to in Annex A is subject to possession of certain qualifications shall ensure that any beneficiaries who apply therefor be provided, before they establish themselves or before they begin to provide services, with information as to the rules governing the occupation which they propose to pursue.TITLE IIRecognition of formal qualifications awarded by another Member StateArticle 31. Without prejudice to Article 4, a Member State may not, on the grounds of inadequate qualifications, refuse to permit a national of another Member State to take up or pursue any of the activities listed in Part One of Annex A on the same conditions as apply to its own nationals, without having first compared the knowledge and skills certified by the diplomas, certificates or other evidence of formal qualifications obtained by the beneficiary with a view to pursuing the same activity elsewhere in the Community with those required under its own national rules. Where the comparative examination shows that the knowledge and skills certified by a diploma, certificate or other evidence of formal qualifications awarded by another Member State correspond to those required by the national rules, the host Member State cannot refuse the holder the right to pursue the activity in question. Where, however, the comparative examination shows a substantial difference, the host Member State shall give the beneficiary the opportunity to demonstrate that he has acquired the knowledge and skills which were lacking. In this case, the host Member State shall give the applicant the right to choose between an adaptation period and an aptitude test by analogy with Directives 89/48/EEC and 92/51/EEC.By way of derogation from this rule, the host Member State may require an adaptation period or an aptitude test if the migrant envisages exercising professional activities in a self-employed capacity or as a manager of an undertaking which are covered by Part One of Annex A and which require the knowledge and the application of the specific national rules in force, provided that knowledge and application of those rules are required by the competent authorities of the host Member State for access to such activities by its own nationals.Member States shall endeavour to take into consideration the beneficiary's preference as between those alternatives.2. Applications for recognition within the meaning of paragraph 1 shall be examined within the shortest possible time, and the competent authority in the host Member State shall state its reasons when giving a decision, which shall be taken no later than four months from the date on which the application and comprehensive supporting documentation were submitted. There shall be a right to appeal under national law against a decision or against the absence of such decision.TITLE IIIRecognition of professional qualifications on the basis of professional experience acquired in another Member StateArticle 4Where, in a Member State, the taking-up or pursuit of any activity listed in Annex A is subject to possession of general, commercial or professional knowledge and ability, that Member State shall accept as sufficient evidence of such knowledge and ability the fact that the activity in question has been pursued in another Member State. Where the activity is mentioned in Part One of Annex A, it must have been pursued:1. in the case of the activities in List I:(a) for six consecutive years in either a self-employed capacity or as a manager of an undertaking; or(b) for three consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements; or(c) for three consecutive years in a self-employed capacity where the beneficiary proves that he has pursued the activity in question for at least five years in an employed capacity; or(d) for five consecutive years in a managerial capacity of which at least three years were spent in technical posts with responsibility for one or more departments of the undertaking where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements.In the cases referred to in (a) and (c), pursuit of the activity shall not have ceased more than ten years before the date on which the application under Article 8 is made;2. in the case of the activities in List II:(a) for six consecutive years in either a self-employed capacity or as a manager of an undertaking; or(b) - for three consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements, or- for four consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received at least two years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements, or(c) for three consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has pursued the activity in question for at least five years in an employed capacity; or(d) - for five consecutive years in an employed capacity where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements, or- for six consecutive years in an employed capacity where the beneficiary proves that he has received at least two years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements.In the cases referred to in (a) and (c), pursuit of the activity shall not have ceased more than ten years before the date on which the application provided for in Article 8 is made;3. in the case of the activities in List III:(a) for six consecutive years in either a self-employed capacity or as a manager of an undertaking; or(b) for three consecutive years in a self-employed capacity or as a manager of an undertaking, where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements; or(c) for three consecutive years in a self-employed capacity where the beneficiary proves that he has pursued the activity in question for at least five years in an employed capacity.In the cases referred to in (a) and (c), pursuit of the activity shall not have ceased more than ten years before the date on which the application provided for in Article 8 is made;4. in the case of the activities in List IV:(a) for five consecutive years in either a self-employed capacity or as a manager of an undertaking; or(b) for two consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received at least three years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements; or(c) for three consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received at least two years' prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements; or(d) for two consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has pursued the activity in question for at least three years in an employed capacity; or(e) for three consecutive years in an employed capacity where the beneficiary proves that he has received at least two years' previous training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements;5. in the case of the activities in List V(a) and (b):(a) for three years in a self-employed capacity or as a manager of an undertaking, provided that pursuit of the activity in question did not cease more than two years before the date on which the application provided for in Article 8 is made;(b) for three years in a self-employed capacity or as a manager of an undertaking, provided that pursuit of the activity in question did not cease more than two years before the date on which the application provided for in Article 8 is made, unless the host Member State permits its nationals to interrupt their pursuit of that activity for a longer period; or6. in the case of the activities in List VI:(a) for three consecutive years in either a self-employed capacity or as a manager of an undertaking; or(b) for two consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has received prior training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements; or(c) for two consecutive years in a self-employed capacity or as a manager of an undertaking where the beneficiary proves that he has pursued the activity in question for at least three years in an employed capacity; or(d) for three consecutive years in an employed capacity where the beneficiary proves that he has received previous training for the activity in question, attested by a nationally recognised certificate or regarded by a competent professional or trade body as fully satisfying its requirements.In the cases referred to in (a) and (c), pursuit of the activity shall not have ceased more than 10 years before the date on which the application provided for in Article 8 is made.Article 5Where a beneficiary holds a nationally recognised certificate obtained in a Member State attesting to knowledge of and ability in the activity in question equivalent to at least two or three years, as appropriate, of professional training, that certificate may be treated by the host Member State in the same way as a certificate attesting to training of the duration required by Article 4(1)(b) and (d), (2)(b) and (d), (3)(b) and (4)(b), (c) and (e).Article 6Where the duration of the training of the beneficiary is at least two years and less than three years, the requirements of Article 4 shall be satisfied if the duration of professional experience in a self-employed capacity or as a manager specified in Article 4(1)(b) and (d), (2)(b), first indent, (3)(b) and (4)(b) or in an employed capacity specified in Article 4(2)(d), first indent is extended in the same proportion to cover the difference in the duration of the training.Article 7A person shall be regarded as having pursued an activity as a manager of an undertaking within the meaning of Article 4 if he has pursued such an activity in an undertaking in the occupational field in question:(a) as a manager of an undertaking or a manager of a branch of an undertaking; or(b) as a deputy to the proprietor or the manager of an undertaking where that post involves responsibility equivalent to that of the proprietor or manager represented; or(c) in a managerial post with duties of a commercial and/or technical nature and with responsibility for one or more departments of the undertaking.Article 8Proof that the conditions laid down in Article 4 are satisfied shall be established by a certificate concerning the nature and duration of the activity issued by the competent authority or body in the home Member State or in the Member State from where the beneficiary comes which the beneficiary must submit in support of his application for authorisation to pursue the activity or activities in question in the host Member State.TITLE IVRecognition of other professional qualifications obtained in another Member StateArticle 91. Where a host Member State requires its own nationals wishing to take up any activity referred to in Article 1(2) to furnish proof of good character and proof that they are not and have not previously been declared bankrupt, or proof of either of these, it shall accept as sufficient evidence, in respect of nationals of other Member States, the production of an extract from the "judicial record" or, failing this, of an equivalent document issued by a competent judicial or administrative authority in the home Member State or in the Member State from where the beneficiary comes showing that these requirements are satisfied.2. Where a host Member State imposes on its own nationals wishing to take up any activity referred to in Article 1(2) certain requirements as to good character and requires them to prove that they are not and have not previously been declared bankrupt and have not previously been the subject of professional or administrative disciplinary measures (for example, withdrawal of the right to hold certain offices, suspension from practice or striking-off), but proof cannot be obtained from the document referred to in paragraph 1 of this Article, it shall accept as sufficient evidence in respect of nationals of other Member States a certificate issued by a competent judicial or administrative authority in the home Member State or in the Member State from where the beneficiary comes attesting that the requirements are satisfied. Such certificate shall relate to the specific facts regarded as relevant by the host Member State.3. Where the home Member State or the Member State from where the beneficiary comes does not issue the documents referred to in paragraphs 1 and 2, such documents shall be replaced by a declaration on oath - or, in those Member States where there is no provision for such declaration on oath, by a solemn declaration - made by the person concerned before a competent judicial or administrative authority or, where appropriate, a notary in that Member State; such authority or notary shall issue a certificate attesting the authenticity of the declaration on oath or solemn declaration. The declaration of no previous bankruptcy may also be made before a competent professional or trade body in that Member State.4. Where a host Member State requires proof of financial standing, it shall regard certificates issued by banks in the home Member State or in the Member State from where the beneficiary comes as equivalent to those issued in its own territory.5. Where a host Member State requires its own nationals wishing to take up or pursue any activity referred to in Article 1(2) to furnish proof that they are insured against the financial risks arising from their professional liability, it shall accept certificates issued by the insurance undertakings of other Member States as equivalent to those issued in its own territory. Such certificates shall state that the insurer has complied with the laws and regulations in force in the host Member State regarding the terms and extent of cover.6. At the time of their production, the documents referred to in paragraphs 1, 2, 3 and 5 may not date from more than three months after their date of issue.TITLE VProcedural provisionsArticle 101. Member States shall designate, within the period stipulated in Article 14, the authorities and bodies responsible for issuing the certificates referred to in Articles 8 and 9(1), (2) and (3) and shall communicate this information forthwith to the other Member States and to the Commission.2. Each Member State may nominate a coordinator for the activities of the authorities and bodies referred to in paragraph 1 to the coordinating group set up under Article 9(2) of Directive 89/48/EEC. The tasks of the coordinating group shall also be as follows:- facilitating the implementation of this Directive;- collecting all useful information for its application in the Member States and especially gathering and comparing information on the different professional qualifications in the areas of activity falling within the scope of this Directive.TITLE VIFinal provisionsArticle 111. The Directives listed in Annex B are hereby repealed.2. References to the repealed Directives shall be construed as references to this Directive.Article 12As from 1 January 2001, Member States shall communicate to the Commission every two years a report on the application of the system introduced.In addition to general remarks, that report shall contain a statistical summary of the decisions taken and a description of the main problems arising from the application of this Directive.Article 13Not later than five years after the date referred to in Article 14, the Commission shall report to the European Parliament and the Council on the state of application of this Directive, and in particular of Article 5, in the Member States.After undertaking all the necessary hearings, especially of the coordinators, the Commission shall submit its conclusions regarding any changes to the existing arrangement. If necessary, the Commission shall also submit proposals for improving the existing arrangements with the aim of facilitating free movement of persons, the right of establishment and freedom to provide services.Article 141. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 31 July 2001. They shall immediately inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member States.2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.Article 15This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 16This Directive is addressed to the Member States.Done at Luxembourg, 7 June 1999.For the European ParliamentThe PresidentJ. M. GIL-ROBLESFor the CouncilThe PresidentE. BULMAHN(1) OJ C 115, 19.4.1996, p. 16 andOJ C 264, 30.8.1997, p. 5.(2) OJ C 295, 7.10.1996, p. 43.(3) Opinion of the European Parliament of 20 February 1997 (OJ C 85, 17.3.1997, p. 114), Common Position of the Council of 29 June 1998 (OJ C 262, 19.8.1998, p. 12), Decision of the European Parliament of 8 October 1998 (OJ C 328, 26.10.1998, p. 156). Decision of the European Parliament of 7 May 1999 and Council Decision of 11 May 1999.(4) OJ L 19, 24.1.1989, p. 16.(5) OJ L 209, 24.7.1992, p. 25. Directive as last amended by Commission Directive 97/38/EC (OJ L 184, 12.7.1997, p. 31).(6) Council Directive 77/452/EEC of 27 June 1977 concerning the mutual recognition of diplomas, certificates and other evidence of the formal qualifications of nurses responsible for general care, including measures to facilitate the effective exercise of this right of establishment and freedom to provide services (OJ L 176, 15.7.1977, p. 1). Directive as last amended by Directive 90/658/EC (OJ L 353, 17.12.1990, p. 73).(7) OJ 2, 15.1.1962, p. 32/62.(8) OJ 2, 15.1.1962, p. 36/62.ANNEX APART ONEActivities related to categories of professional experienceList IMajor Groups covered by Directive 64/427/EEC, as amended by Directive 69/77/EEC, and by Directives 68/366/EEC, 75/368/EEC and 75/369/EEC1Directive 64/427/EEC(liberalisation Directive: 64/429/EEC)NICE Nomenclature (corresponding to ISIC Major Groups 23-40)>TABLE>2Directive 68/366/EEC(liberalisation Directive 68/365/EEC)NICE Nomenclature>TABLE>3Directive 75/368/EEC (activities listed in Article 5(1 ))ISIC Nomenclature>TABLE>4Directive 75/369/EEC (Article 6: where the activity is regarded as being of an industrial or small-craft nature)ISIC NomenclatureThe following itinerant activities:(a) the buying and selling of goods:- by itinerant tradesmen, hawkers or pedlars (ex ISIC Group 612);- in covered markets other than from permanently fixed installations and in open-air markets;(b) activities covered by transitional measures already adopted that expressly exclude or do not mention the pursuit of such activities on an itinerant basis.List IIDirective 82/470/EEC (Article 6(3))Groups 718 and 720 of the ISIC NomenclatureThe activities comprise in particular:- organizing, offering for sale and selling, outright or on commission, single or collective items (transport, board, lodging, excursions, etc.) for a journey or stay, whatever the reasons for travelling (Article 2(B)(a)).List IIIDirective 82/489/EEC>TABLE>List IVDirective 82/470/EEC (Article 6(1))Groups 718 and 720 of the ISIC Nomenclature:The activities comprise in particular:- acting as an intermediary between contractors for various methods of transport and persons who dispatch or receive goods, and carrying out related activities:(aa) by concluding contracts with transport contractors, on behalf of principals;(bb) by choosing the method of transport, the firm and the route considered most profitable for the principal;(cc) by arranging the technical aspects of the transport operation (e.g. packing required for transportation); by carrying out various operations incidental to transport (e.g. ensuring ice supplies for refrigerated wagons);(dd) by completing the formalities connected with the transport such as the drafting of way bills; by assembling and dispersing shipments;(ee) by coordinating the various stages of transportation, by ensuring transit, reshipment, transshipment and other termination operations;(ff) by arranging both freight and carriers and means of transport for persons dispatching goods or receiving them;- assessing transport costs and checking the detailed accounts;- taking certain temporary or permanent measures in the name of and on behalf of a shipowner or sea transport carrier (with the port authorities, ship's chandlers, etc.)(The activities listed under Article 2(A)(a), (b) and (d)).List VDirectives (64/222/EEC) and (70/523/EEC)(a)See Article 4(5)(a) of this DirectiveDirective 64/222/EEC(liberalisation Directive 64/224/EEC)1. professional activities of an intermediary who is empowered and instructed by one or more persons to negotiate or enter into commercial transactions in the name of and on behalf of those persons;2. professional activities of an intermediary who, while not being permanently so instructed, brings together persons wishing to contract directly with one another or arranges their commercial transactions or assists in the completion thereof;3. professional activities of an intermediary who enters into commercial transactions in his own name on behalf of others;4. professional activities of an intermediary who carries out wholesale selling by auction on behalf of others;5. professional activities of an intermediary who goes from door to door seeking orders;6. provision of services, by way of professional activities, by an intermediary in the employment of one or more commercial, industrial or small craft undertakings.(b)See Article 4(5)(b) of this DirectiveDirective 70/523/EECActivities of self-employed persons in the wholesale coal trade and activities of intermediaries in the coal trade (ex Group 6112, ISIC Nomenclature)List VIDirectives 68/364/EEC, 68/368/EEC, 75/368/EEC, 75/369/EEC, 82/470/EEC1Directive 68/364/EEC(liberalisation Directive 68/363/EEC)>TABLE>>TABLE>2Directive 68/368/EEC(liberalisation Directive 68/367/EEC)ISIC NomenclatureISIC ex Major Group 85:1. Restaurants, cafes, taverns and other drinking and eating places (ISIC Group 852)2. Hotels, rooming houses, camps and other lodging places (ISIC Group 853)3Directive 75/368/EEC (Article 7)All the activities listed in the Annex to Directive 75/368/EEC, except those referred to in Article 5 of that Directive (List I, No 3 of this Annex).>TABLE>4Directive 75/369/EEC (Article 5)The following itinerant activities:(a) the buying and selling of goods:- by itinerant tradesmen, hawkers or pedlars (ex ISIC Group 612);- in covered markets other than from permanently fixed installations and in open-air markets;(b) activities covered by transitional measures already adopted that expressly exclude or do not mention the pursuit of such activities on an itinerant basis.5Directive 82/470/EEC (Article 6(2))(Activities listed in Article 2(A)(c) and (e), (B)(b), (C) and (D))These activities comprise in particular:- hiring railway cars or wagons for transporting persons or goods;- acting as an intermediary in the sale, purchase or hiring of ships;- arranging, negotiating and concluding contracts for the transport of emigrants;- receiving all objects and goods deposited, on behalf of the depositor, whether under customs control or not, in warehouses, general stores, furniture depots, coldstores, silos, etc.- supplying the depositor with a receipt for the object or goods deposited;- providing pens, feed and sales rings for livestock being temporarily accommodated while awaiting sale or while in transit to or from the market;- carrying out inspection or technical valuation of motor vehicles;- measuring, weighing and gauging goods.PART TWOActivities other than those covered in Part One1Directives 63/261/EEC, 63/262/EEC, 65/1/EEC, 67/530/EEC, 67/531/EEC, 67/532/EEC, 68/192/EEC, 68/415/EEC and 71/18/EECISIC Nomenclature>TABLE>In particular:(a) general agriculture including the growing of field crops and viticulture; growing of fruits, nuts, seeds, vegetables, flowers, both in the open and under glass;(b) raising of livestock, poultry, rabbits, fur-bearing or other animals, bees; the production of meat, milk, wool, skins and fur, eggs, honey;(c) agricultural, animal husbandry and horticultural services on a fee or contract basis.2Directive 63/607/EEC(Films)3Directive 64/223/EECISIC Nomenclature>TABLE>4Directive 64/428/EECNICE Nomenclature>TABLE>5Directive 65/264/EEC(cinema)6Directive 66/162/EECISIC Nomenclature>TABLE>7Directive 67/43/EECISIC Nomenclature>TABLE>8Directive 67/654/EECISIC Nomenclature>TABLE>9Directives 68/369/EEC and 70/451/EECISIC Nomenclature>TABLE>10Directive 69/82/EECISIC Nomenclature>TABLE>11Directive 70/522/EECISIC Nomenclature>TABLE>ANNEX BREPEALED DIRECTIVESPART ONE: LIBERALISATION DIRECTIVES>TABLE>PART TWO: DIRECTIVES PROVIDING FOR TRANSITIONAL MEASURES>TABLE>


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31993L0087

Commission Directive 93/87/EEC of 22 October 1993 amending Directive 90/377/EEC with regard to the survey locations and regions in the Federal Republic of Germany

Official Journal L 277 , 10/11/1993 P. 0032 - 0032 Finnish special edition: Chapter 12 Volume 2 P. 0171  Swedish special edition: Chapter 12 Volume 2 P. 0171

COMMISSION DIRECTIVE 93/87/EEC of 22 October 1993 amending Directive 90/377/EEC with regard to the survey locations and regions in the Federal Republic of GermanyTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 90/377/EEC of 29 June 1990 concerning a Community procedure to improve the transparency of gas and electricity prices charged to industrial end-users (1),  Having regard to Council Directive 90/653/EEC of 4 December 1990 laying down amendments for the purpose of implementing in Germany certain Community Directives relating to statistics on the carriage of goods and statistics on gas and electricity prices  (2),  Whereas Germany has defined the locations in the territory of the former German Democratic Republic in order to extend the breakdown by region and location for statistics on gas and electricity prices;  Whereas the Advisory Committee established by Article 7 of Council Directive 90/377/EEC has been consulted on the measures laid down in the present Directive,  HAS ADOPTED THIS DIRECTIVE:   Article 1  The Annexes to Directive 90/377/EEC shall be amended in order to add the following locations and regions for the collection of gas and electricity prices in the Federal Republic of Germany:  (a) in Annex I, point 11 - Federal Republic of Germany:  - 'Dresden and Berlin';  (b) in Annex II, point 2 - Federal Republic of Germany:  - 'Erfurt, Leipzig and Rostock';  (c) in Annex II, point 13 - Federal Republic of Germany:  - 'East';  (d) footnote 2 to Annex II, point 13 shall be replaced by the following:  'The Laender will be divided into four zones, namely:  - North/Central: Schleswig-Holstein, Hamburg, Bremen, Berlin, Lower Saxony, North Hessen,  - West: North-Rhine-Westphalia, Rineland-Palatinate, South Hessen, Saarland,  - South: Baden-Wurttemberg, Bavaria,  - East: all the Laender not included in the other regions.'  Article 2  This Directive is addressed to the Member States.  Done at Brussels, 22 October 1993.  For the Commission Henning CHRISTOPHERSEN Vice-President  (1) OJ No L 185, 17. 7. 1990, p. 16.  (2) OJ No L 353, 17. 12. 1990, p. 46.


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31981L0177

Council Directive 81/177/EEC of 24 February 1981 on the harmonization of procedures for the export of Community goods

Official Journal L 083 , 30/03/1981 P. 0040 - 0047 Spanish special edition: Chapter 02 Volume 7 P. 0253  Portuguese special edition Chapter 02 Volume 7 P. 0253

++++COUNCIL DIRECTIVE  OF 24 FEBRUARY 1981  ON THE HARMONIZATION OF PROCEDURES FOR THE EXPORT OF COMMUNITY GOODS   ( 81/177/EEC )  THE COUNCIL OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY , AND IN PARTICULAR ARTICLE 100 THEREOF ,  HAVING REGARD TO THE PROPOSAL FROM THE COMMISSION ,  HAVING REGARD TO THE OPINION OF THE EUROPEAN PARLIAMENT ( 1 ) ,  HAVING REGARD TO THE OPINION OF THE ECONOMIC AND SOCIAL COMMITTEE ( 2 ) ,  WHEREAS THE COMMUNITY IS BASED UPON A CUSTOMS UNION ;  WHEREAS , WITHOUT PREJUDICE TO THE TRANSITIONAL MEASURES LAID DOWN IN TITLE I , CHAPTER 1 , OF PART FOUR OF THE 1972 ACT OF ACCESSION , THE ESTABLISHMENT OF THE CUSTOMS UNION IS GOVERNED IN THE MAIN BY TITLE I , CHAPTER 1 , OF PART TWO OF THE TREATY ; WHEREAS THAT CHAPTER CONTAINS A SERIES OF SPECIFIC PROVISIONS DEALING WITH THE ELIMINATION OF CUSTOMS DUTIES BETWEEN MEMBER STATES , THE ESTABLISHMENT AND PROGRESSIVE INTRODUCTION OF THE COMMON CUSTOMS TARIFF AND THE AUTONOMOUS ALTERATION OR SUSPENSION OF THE DUTIES OF THE LATTER ;  WHEREAS , WHILE ARTICLE 27 OF THE TREATY PROVIDES THAT MEMBER STATES SHALL , BEFORE THE END OF THE FIRST STAGE , IN SO FAR AS MAY BE NECESSARY , TAKE STEPS TO APPROXIMATE THEIR PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION RELATING TO CUSTOMS MATTERS , IT DOES NOT EMPOWER THE COMMUNITY INSTITUTIONS TO ISSUE BINDING PROVISIONS IN THAT FIELD ; WHEREAS , HOWEVER , A THOROUGH EXAMINATION UNDERTAKEN JOINTLY WITH THE MEMBER STATES HAS SHOWN THE NEED IN CERTAIN FIELDS FOR DECISION , BY BINDING ACTS OF THE COMMUNITY , UPON MEASURES ESSENTIAL FOR THE INTRODUCTION OF CUSTOMS ARRANGEMENTS WHICH WILL ENSURE UNIFORM APPLICATION OF THE VARIOUS COMMUNITY PROVISIONS GOVERNING TRADE BETWEEN THE COMMUNITY AND THIRD COUNTRIES ;  WHEREAS THE PROCEDURAL RULES LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION IN THE MEMBER STATES RELATING TO THE EXPORT OF GOODS ARE FRAMED MAINLY IN THE LIGHT OF NATIONAL INTERESTS ; WHEREAS THEY DO NOT ALWAYS TAKE SUFFICIENT ACCOUNT OF THE REQUIREMENTS OF THE CUSTOMS UNION ON WHICH THE COMMUNITY IS BASED ;  WHEREAS THESE PROVISIONS ALSO SHOW CONSIDERABLE DISPARITIES IN CERTAIN CASES , WHICH RESULT IN THE APPLICATION , UNDER DIFFERING CONDITIONS , OF EXPORT DUTIES OF THE OTHER COMMUNITY PROVISIONS TO WHICH THE EXPORT OF COMMUNITY GOODS FROM THE CUSTOMS TERRITORY OF THE COMMUNITY MAY GIVE RISE ; WHEREAS THE RESULTING DISTORTIONS OF TREATMENT FOR COMMUNITY EXPORTERS , DEPENDING ON THE MEMBER STATE IN WHICH THE CUSTOMS CLEARANCE FORMALITIES ARE CARRIED OUT , MAY LEAD TO DEFLECTIONS OF TRADE AND ARTIFICIAL MOVEMENT OF ACTIVITIES ;  WHEREAS THESE PROVISIONS DIRECTLY AFFECT THE ESTABLISHMENT AND OPERATION OF THE COMMON MARKET ;  WHEREAS , TAKING INTO ACCOUNT THE PROGRESS MADE IN CREATING THE CUSTOMS UNION , IT IS NECESSARY TO FIX COMMON RULES OF PROCEDURE FOR THE EXPORT OF COMMUNITY GOODS , FROM THE CUSTOMS TERRITORY OF THE COMMUNITY , IN THE FORM OF A DIRECTIVE AT LEAST ;  WHEREAS THESE COMMON RULES MUST MAKE IT POSSIBLE TO ENSURE THE CORRECT APPLICATION OF BOTH EXPORT DUTIES AND ANY OTHER COMMUNITY PROVISIONS TO WHICH THE EXPORT OF COMMUNITY GOODS FROM THE CUSTOMS TERRITORY OF THE COMMUNITY MAY GIVE RISE ; WHEREAS , HOWEVER , SUCH RULES MUST DISPENSE WITH ALL UNNECESSARY FORMALITIES ; WHEREAS , MOREOVER , THEY MUST BE SUFFICIENTLY FLEXIBLE TO BE ADAPTABLE TO DIFFERING CIRCUMSTANCES AND TO TAKE INTO ACCOUNT PROGRESS IN ADMINISTRATIVE TECHNIQUES , PARTICULARLY WITH REGARD TO DATA PROCESSING ;  WHEREAS IT IS IMPORTANT TO ENSURE UNIFORM APPLICATION OF THESE COMMON RULES AND TO PROVIDE , FOR THIS PURPOSE , A COMMUNITY PROCEDURE WHICH WILL ALLOW THE MEASURES FOR IMPLEMENTING THEM TO BE ADOPTED WITHIN APPROPRIATE TIME LIMITS ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  1 . WITHOUT PREJUDICE TO ANY SPECIAL PROVISIONS WHICH HAVE BEEN , OR WILL BE , ADOPTED UNDER SPECIFIC CUSTOMS ARRANGEMENTS OR THE COMMON AGRICULTURAL POLICY , THIS DIRECTIVE DETERMINES THE RULES WHICH SHALL BE LAID DOWN IN THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS OF THE MEMBER STATES IN RESPECT OF THE EXPORT FROM THE CUSTOMS TERRITORY OF THE COMMUNITY OF GOODS FULFILLING THE CONDITIONS LAID DOWN IN ARTICLE 9 ( 2 ) OF THE TREATY .  GOODS SENT TO THE ISLAND OF HELIGOLAND SHALL NOT BE REGARDED AS EXPORTS FROM THE CUSTOMS TERRITORY OF THE COMMUNITY .  2 . FOR THE PURPOSES OF THIS DIRECTIVE :   ( A ) EXPORT DUTIES MEAN THE AGRICULTURAL LEVIES AND OTHER CHARGES PROVIDED FOR UNDER THE COMMON AGRICULTURAL POLICY OR THE SPECIFIC ARRANGEMENTS APPLICABLE , PURSUANT TO ARTICLE 235 OF THE TREATY , TO CERTAIN GOODS RESULTING FROM THE PROCESSING OF AGRICULTURAL PRODUCTS ;   ( B ) CUSTOMS OFFICE MEANS ANY OFFICE COMPETENT TO ACCEPT THE EXPORT DECLARATION REFERRED TO IN ARTICLE 2 .  3 . COMPONENT PARTS OF INDUSTRIAL PLANT COMING UNDER A SINGLE HEADING IN THE NOMENCLATURE OF GOODS FOR THE EXTERNAL TRADE STATISTICS OF THE COMMUNITY ( NIMEXE ) IN ACCORDANCE WITH THE DECISIONS ADOPTED IN THIS FIELD PURSUANT TO COUNCIL REGULATION ( EEC ) NO 1736/75 OF 24 JUNE 1975 ON THE EXTERNAL TRADE STATISTICS OF THE COMMUNITY AND STATISTICS OF TRADE BETWEEN MEMBER STATES SHALL BE DEEMED TO CONSITUTE A SINGLE ITEM OF GOODS ( 3 ) .  TITLE I  GENERAL PROCEDURE  ARTICLE 2  THE EXPORT FROM THE CUSTOMS TERRITORY OF THE COMMUNITY OF THE GOODS REFERRED TO IN ARTICLE 1 ( 1 ) SHALL BE CONDITIONAL UPON THE LODGING AT A CUSTOMS OFFICE , IN ACCORDANCE WITH THE CONDITIONS LAID DOWN IN THIS DIRECTIVE , OF AN EXPORT DECLARATION ( HEREINAFTER REFERRED TO AS " THE DECLARATION " ) .  THE NATURAL OR LEGAL PERSON WHO MAKES THE DECLARATION SHALL HEREINAFTER BE REFERRED TO AS " THE DECLARANT " .  ARTICLE 3  1 . THE DECLARATION SHALL BE MADE IN WRITING ON A FORM CORRESPONDING TO THE APPROPRIATE OFFICIAL MODEL DETERMINED BY THE COMPETENT AUTHORITIES IN ACCORDANCE WITH THE COMMUNITY PROVISIONS IN FORCE . IT SHALL BE SIGNED AND CONTAIN THE PARTICULARS NECESSARY FOR THE IDENTIFICATION OF THE GOODS AND , WHERE APPROPRIATE , FOR THE APPLICATION OF THE EXPORT DUTIES AND ANY OTHER PROVISIONS GOVERNING THE EXPORT OF THE GOODS .  2 . THE DECLARATION SHALL BE ACCOMPANIED BY ALL THE DOCUMENTS REQUIRED FOR THE CORRECT APPLICATION OF THE EXPORT DUTIES AND ANY OTHER PROVISIONS GOVERNING THE EXPORT OF THE GOODS .  ARTICLE 4  FOR THE PURPOSE OF MAKING THE DECLARATION AND IN SO FAR AS THE GOODS TO BE EXPORTED ARE UNDER A SPECIFIC CUSTOMS PROCEDURE , THE CUSTOMS AUTHORITY SHALL , UNDER CONDITIONS WHICH IT SHALL SPECIFY , AUTHORIZE THE PRIOR EXAMINATION OF THE SAID GOODS AND THE TAKING OF SAMPLES .  ARTICLE 5  1 . THE GOODS TO BE EXPORTED SHALL BE PRESENTED AT ANY COMMUNITY CUSTOMS OFFICE WHICH IS COMPETENT , IN ACCORDANCE WITH THE PROVISIONS IN FORCE IN THE MEMBER STATE TO WHICH THE OFFICE IS RESPONSIBLE , TO COMPLETE THE EXPORT FORMALITIES RELATING THERETO .  WHERE GOODS ARE CONSIGNED DIRECT FROM A MEMBER STATE TO A PARTICULAR THIRD COUNTRY , THE COMPETENT AUTHORITIES OF THE MEMBER STATE IN QUESTION MAY REQUIRE THE GOODS TO BE PRESENTED AT A COMPETENT CUSTOMS OFFICE WITHIN ITS AUTHORITY .  2 . THE DECLARATION SHALL BE LODGED AT THE CUSTOMS OFFICE AT WHICH THE GOODS ARE PRESENTED . IT MAY BE LODGED ONCE THE GOODS HAVE BEEN PRESENTED THERE .  HOWEVER , THE CUSTOMS AUTHORITY MAY AUTHORIZE THE DECLARATION TO BE LODGED BEFORE THE DECLARANT IS IN A POSITION TO PRESENT THE GOODS . IN THIS CASE , THE CUSTOMS AUTHORITY MAY SET A TIME LIMIT , TO BE DETERMINED ACCORDING TO THE CIRCUMSTANCES , FOR PRESENTATION OF THE GOODS . IF THE GOODS HAVE NOT BEEN PRESENTED WITHIN THIS TIME LIMIT , THE DECLARATION SHALL BE DEEMED NOT TO HAVE BEEN LODGED .  3 . FOR THE PURPOSES OF APPLYING PARAGRAPHS 1 AND 2 , GOODS SHALL BE DEEMED TO HAVE BEEN PRESENTED AT A CUSTOMS OFFICE WHEN THEIR PRESENCE AT THAT CUSTOMS OFFICE , OR AT ANOTHER PLACE DESIGNATED BY THE COMPETENT AUTHORITIES , HAS BEEN NOTIFIED TO THE LATTER IN THE MANNER REQUIRED TO ENABLE THEM TO CONTROL OR INSPECT THEM .  4 . THE DECLARATION SHALL BE LODGED AT THE COMPETENT CUSTOMS OFFICE DURING THE DAYS AND HOURS APPOINTED FOR OPENING .  HOWEVER , THE CUSTOMS AUTHORITY MAY , AT THE REQUEST OF THE DECLARANT AND AT HIS EXPENSE , AUTHORIZE THE DECLARATION TO BE LODGED OUTSIDE THE APPOINTED DAYS AND TIMES .  5 . ANY DECLARATION LODGED WITH THE OFFICIALS OF A CUSTOMS OFFICE IN ANY OTHER PLACE DULY DESIGNATED FOR THAT PURPOSE BY AGREEMENT BETWEEN THE COMPETENT AUTHORITIES AND THE PERSON CONCERNED SHALL BE REGARDED AS HAVING BEEN LODGED IN THE AFOREMENTIONED OFFICE .  6 . THIS ARTICLE SHALL NOT PRECLUDE THE APPLICATION OF NATIONAL PROVISIONS WHICH THE MEMBER STATES MAY ADOPT ON THE BASIS OF ARTICLE 36 OF THE TREATY , WHEN THE GOODS DECLARED IN A MEMBER STATE FOR EXPORT OUTSIDE THE CUSTOMS TERRITORY OF THE COMMUNITY ARE REQUIRED TO PASS THROUGH THE TERRITORY OF ANOTHER MEMBER STATE .  ARTICLE 6  1 . ONLY DECLARATIONS WHICH COMPLY WITH THE CONDITIONS LAID DOWN IN ARTICLE 3 MAY BE ACCEPTED BY THE CUSTOMS AUTHORITY . SUCH DECLARATIONS SHALL BE ACCEPTED BY THE CUSTOMS AUTHORITY FORTHWITH IN ACCORDANCE WITH THE PROCEDURES LAID DOWN IN EACH MEMBER STATE .  HOWEVER , WHERE , PURSUANT TO ARTICLE 5 ( 2 ) , SECOND SUBPARAGRAPH , A DECLARATION HAS BEEN LODGED BEFORE THE GOODS TO WHICH IT RELATES HAVE ARRIVED AT THE CUSTOMS OFFICE OR AT ANOTHER PLACE DESIGNATED BY THE CUSTOMS AUTHORITY , IT MAY BE ACCEPTED ONLY AFTER THE GOODS IN QUESTION HAVE BEEN PRESENTED TO THE COMPETENT AUTHORITIES , WITHIN THE MEANING OF ARTICLE 5 ( 3 ) .  2 . MEMBER STATES SHALL TAKE ALL NECESSARY STEPS TO ENSURE THAT THE DATE OF ACCEPTANCE OF EACH DECLARATION CAN BE CLEARLY ESTABLISHED FOR THE PURPOSE OF DETERMINING THE OPERATIVE DATE FOR THE APPLICATION OF ARTICLE 11 , WHERE APPROPRIATE .  ARTICLE 7  1 . THE DECLARANT SHALL , AT HIS REQUEST , BE AUTHORIZED TO CORRECT DECLARATIONS ACCEPTED BY THE CUSTOMS AUTHORITY UNDER THE CONDITIONS LAID DOWN IN ARTICLE 6 , AS REGARDS ONE OR MORE OF THE PARTICULARS REFERRED TO IN ARTICLE 3 ( 1 ) , SUBJECT TO THE FOLLOWING :   ( A ) THE CORRECTION SHALL BE REQUESTED BEFORE THE GOODS ARE RELEASED FROM THE CUSTOMS OFFICE OR PLACE DESIGNATED FOR THAT PURPOSE , UNLESS THE REQUEST RELATES TO DETAILS WHICH THE CUSTOMS AUTHORITY CAN CHECK AS BEING CORRECT WITHOUT THE GOODS BEING PRESENT ;   ( B ) THE CORRECTION MAY NO LONGER BE ALLOWED WHERE THE REQUEST IS MADE AFTER THE CUSTOMS AUTHORITY HAS INFORMED THE DECLARANT THAT IT INTENDS TO EXAMINE THE GOODS OR THAT IT HAS ITSELF ESTABLISHED THAT THE PARTICULARS IN QUESTION ARE INCORRECT ;   ( C ) THE CORRECTION SHALL NOT RESULT IN THE APPLICATION OF THE DECLARATION TO GOODS OTHER THAN THOSE TO WHICH IT ORIGINALLY RELATED .  2 . THE CUSTOMS AUTHORITY MAY ALLOW OR REQUIRE THAT THE CORRECTIONS REFERRED TO IN PARAGRAPH 1 BE MADE BY THE LODGING OF A NEW DECLARATION INTENDED TO REPLACE THE ORIGINAL DECLARATION . IN THAT EVENT , THE DATE FOR DETERMINING THE EXPORT DUTIES RELATING TO THE GOODS IN QUESTION AND FOR THE APPLICATION OF ANY OTHER EXPORT PROVISIONS SHALL BE THAT OF THE ACCEPTANCE OF THE ORIGINAL DECLARATION .  ARTICLE 8  1 . SO LONG AS THE GOODS HAVE NOT LEFT THE CUSTOMS TERRITORY OF THE COMMUNITY , THE DECLARANT MAY REQUEST THAT THE RELEVANT DECLARATION BE CANCELLED OR , WHERE THE LEGISLATION OF THE MEMBER STATE CONCERNED DOES NOT PERMIT SUCH CANCELLATION , THAT IT BE INVALIDATED .  HOWEVER , WHEN THE CUSTOMS AUTHORITY HAS INFORMED THE DECLARANT OF ITS INTENTION TO EXAMINE THE GOODS IN RESPECT OF WHICH THE DECLARATION WAS MADE , A REQUEST FOR CANCELLATION OR INVALIDATION MAY NOT BE MADE UNTIL THIS EXAMINATION HAS TAKEN PLACE .  2 . THE CUSTOMS AUTHORITY SHALL NOT AUTHORIZE THE CANCELLATION OR INVALIDATION OF THE DECLARATION UNLESS THE DECLARANT :   ( A ) PROVIDES THE COMPETENT AUTHORITIES WITH PROOF THAT THE GOODS HAVE NOT LEFT THE CUSTOMS TERRITORY OF THE COMMUNITY ;   ( B ) RETURNS TO THE SAID COMPETENT AUTHORITIES ALL COPIES OF THE EXPORT DECLARATION , TOGETHER WITH ANY OTHER DOCUMENTS DELIVERED TO HIM ON ACCEPTANCE OF THE DECLARATION ;   ( C ) WHERE APPROPRIATE , PROVIDES THE COMPETENT AUTHORITIES WITH PROOF THAT THE REFUNDS AND OTHER AMOUNTS GRANTED ON THE STRNGTH OF THE EXPORT DECLARATION FOR THE GOODS IN QUESTION HAVE BEEN REPAID OR THAT THE NECESSARY MEASURES HAVE BEEN TAKEN BY THE SERVICES CONCERNED SO THAT THEY ARE NOT PAID ;   ( D ) WHERE APPROPRIATE , AND IN ACCORDANCE WITH THE PROVISIONS IN FORCE , COMPLIES WITH THE OTHER OBLIGATIONS WHICH MAY BE SET BY THE COMPETENT AUTHORITIES TO REGULARIZE THE POSITION OF THE GOODS .  3 . THE CANCELLATION OR INVALIDATION OF THE DECLARATION SHALL , WHERE APPROPRIATE , RESULT IN THE CANCELLATION OF ATTRIBUTIONS ON ANY EXPORT LICENCE OR ADVANCE-FIXING CERTIFICATE PRESENTED IN SUPPORT OF THE DECLARATION .  4 . THE CANCELLATION OR INVALIDATION OF THE DECLARATION SHALL IN NO WAY PRECLUDE THE APPLICATION OF SANCTIONS FOR AN OFFENCE COMMITTED BY THE DECLARANT .  5 . WHERE THE GOODS DECLARED FOR EXPORT ARE REQUIRED TO LEAVE THE CUSTOMS TERRITORY OF THE COMMUNITY WITHIN A SPECIFIED PERIOD , FAILURE TO RESPECT THE TIME LIMIT SHALL RESULT , IN THE CANCELLATION OR INVALIDATION OF THE RELEVANT DECLARATION , EXCEPT WHERE THE TIME LIMIT IS EXTENDED BY THE COMPETENT AUTHORITIES .  IN THE SITUATION REFERRED TO IN THE FIRST SUBPARAGRAPH , PARAGRAPH 2 ( B ) , ( C ) AND ( D ) AND PARAGRAPH 3 AND 4 SHALL APPLY .  ARTICLE 9  1 . WITHOUT PREJUDICE TO ANY OTHER MEANS OF CONTROL AT ITS DISPOSAL , THE CUSTOMS AUTHORITY MAY EXAMINE ALL OR PART OF THE DECLARED GOODS .  2 . THE GOODS SHALL BE EXAMINED IN THE PLACES DESIGNATED AND DURING THE HOURS APPOINTED FOR THAT PURPOSE .  HOWEVER , THE CUSTOMS AUTHORITY MAY , AT THE REQUEST OF THE DECLARANT , AUTHORIZE THE EXAMINATION OF GOODS IN PLACES OR DURING HOURS OTHER THAN THOSE REFERRED TO ABOVE . ANY COSTS INVOLVED SHALL BE BORNE BY THE DECLARANT .  3 . TRANSPORT OF THE GOODS TO THE PLACES WHERE THEY ARE TO BE EXAMINED , UNPACKING , REPACKING AND ALL OTHER OPERATIONS NECESSITATED BY SUCH EXAMINATION SHALL BE CARRIED OUT BY THE DECLARANT OR ON HIS RESPONSIBILITY . IN ALL CASES , ANY COSTS INVOLVED SHALL BE BORNE BY THE DECLARANT .  4 . THE DECLARANT SHALL BE ENTITLED TO BE PRESENT AT THE EXAMINATION OF THE GOODS OR TO BE REPRESENTED AT IT . IF THE CUSTOMS AUTHORITY SEES FIT , IT MAY REQUIRE THE DECLARANT TO BE PRESENT AT THE EXAMINATION OF THE GOODS , OR TO BE REPRESENTED AT IT IN ORDER TO ASSIST WITH THE EXAMINATION , AS NECESSARY .  5 . WHEN EXAMINING THE GOODS , THE CUSTOMS AUTHORITY MAY TAKE SAMPLES FOR ANALYSIS OR FOR MORE DETAILED EXAMINATION . THE COSTS ARISING FROM SUCH ANALYSIS OR MORE DETAILED EXAMINATION SHALL BE BORNE BY THE ADMINISTRATIVE AUTHORITY .  6 . PARAGRAPH 5 SHALL NOT PRECLUDE APPLICATION OF ARTICLE 8 ( 2 ) OF COUNCIL REGULATION ( EEC ) NO 3035/80 OF 11 NOVEMBER 1980 LAYING DOWN GENERAL RULES FOR GRANTING EXPORT REFUNDS ON CERTAIN AGRICULTURAL PRODUCTS EXPORTED IN THE FORM OF GOODS NOT COVERED BY ANNEX II TO THE TREATY , AND THE CRITERIA FOR FIXING THE AMOUNT OF SUCH REFUNDS ( 4 ) .  ARTICLE 10  1 . THE RESULT OF THE EXAMINATION OF THE DECLARATION AND THE DOCUMENTS ATTACHED TO IT , WHETHER OR NOT COMBINED WITH EXAMINATION OF THE GOODS , SHALL BE USED FOR CALCULATING THE EXPORT DUTIES OR EXPORT REFUNDS AND OTHER EXPORT AMOUNTS AND FOR APPLYING ANY OTHER COMMUNITY PROVISIONS GOVERNING EXPORT OF THE GOODS . WHERE NEITHER THE DECLARATION AND THE DOCUMENTS ATTACHED TO IT , NOR THE GOODS THEMSELVES , ARE EXAMINED , SUCH DUTIES SHALL BE CALCULATED AND SUCH PROVISIONS APPLIED ON THE BASIS OF THE PARTICULARS CONTAINED IN THE DECLARATION .  2 . PARAGRAPH 1 SHALL BE WITHOUT PREJUDICE TO EITHER ANY SUBSEQUENT VERIFICATION BY THE COMPETENT AUTHORITIES OF THE MEMBER STATES OR THE POSSIBLE CONSEQUENCES OF APPLYING THE PROVISIONS IN FORCE , PARTICULARLY AS REGARDS ANY CHANGE IN THE AMOUNT OF THE EXPORT DUTIES CHARGED ON THE GOODS OR OF THE EXPORT REFUNDS OR OTHER EXPORT AMOUNTS WHICH HAVE BEEN GRANTED .  ARTICLE 11  THE DATE OF ACCEPTANCE OF THE DECLARATION SHALL BE THE OPERATIVE DATE FOR :   ( A ) DETERMINING THE RATES OR AMOUNTS OF EXPORT DUTIES TO WHICH THE GOODS MAY BE SUBJECT , AS WELL AS OTHER PARTICULARS MATERIAL TO THE CALCULATION OF SUCH DUTIES ;   ( B ) APPLYING ANY OTHER COMMUNITY PROVISIONS GOVERNING EXPORT OF THE GOODS .  ARTICLE 12  WITHOUT PREJUDICE TO ANY CHANGES WHICH MAY OCCUR PURSUANT TO ARTICLE 10 ( 2 ) , THE AMOUNT OF THE EXPORT DUTIES DETERMINED BY THE COMPETENT AUTHORITIES SHALL BE ENTERED IN THE ACCOUNTS BY THE LATTER UNDER THE PROCEDURE LAID DOWN FOR THAT PURPOSE AND SHALL BE COMMUNICATED TO EITHER THE DECLARANT OR THE PERSON WHOM HE REPRESENTS , WHOMEVER THE AUTHORITIES CHOOSE .  ARTICLE 13  WITHOUT PREJUDICE TO THE APPLICATION OF ANY PROHIBITIVE OR RESTRICTIVE MEASURES PROVIDED FOR IN RESPECT OF THE GOODS DECLARED FOR EXPORT , THE CUSTOMS AUTHORITY MAY AUTHORIZE EXPORT OF THE GOODS ONLY IF IT IS SATISFIED , WHERE APPROPRIATE , THAT THE DUTIES ENTERED IN THE ACCOUNTS IN ACCORDANCE WITH ARTICLE 12 HAVE BEEN PAID OR GUARANTEED OR THAT PAYMENT OF THEM HAS BEEN DEFERRED UNDER THE CONDITIONS LAID DOWN IN COUNCIL DIRECTIVE 78/453/EEC OF 22 MAY 1978 ON THE HARMONIZATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION CONCERNING DEFERRED PAYMENT OF IMPORT DUTIES OR EXPORT DUTIES ( 5 ) .  ARTICLE 14  1 . THE CUSTOMS AUTHORITY ITSELF SHALL DECIDE THE FORM IN WHICH IT AUTHORIZES EXPORT OF THE GOODS , TAKING DUE ACCOUNT OF THE PLACE IN WHICH THE SAID GOODS ARE TREATED AND OF THE SPECIAL PROCEDURES FOR THEIR CONTROL .  2 . GOODS WHICH HAVE RECEIVED AN EXPORT AUTHORIZATION SHALL REMAIN UNDER CUSTOMS CONTROL UNTIL THEY LEAVE THE CUSTOMS TERRITORY OF THE COMMUNITY .  TITLE II  SIMPLIFIED PROCEDURES  ARTICLE 15  1 . FROM 1 JANUARY 1984 AT THE LATEST , MEMBER STATES SHALL NO LONGER APPLY SIMPLIFIED PROCEDURES OTHER THAN THOSE LAID DOWN IN ARTICLES 16 TO 20 .  THEY SHALL APPLY FROM THAT DATE ALL SUCH SIMPLIFIED PROCEDURES IN SO FAR AS THEIR ADMINISTRATIVE ORGANIZATION ALLOWS IT .  2 . RECOURSE TO ANY OF THE SIMPLIFIED PROCEDURES LAID DOWN IN ARTICLES 16 TO 20 SHALL BE CONDITIONAL UPON AN AUTHORIZATION FROM THE COMPETENT AUTHORITIES OF THE MEMBER STATE IN WHICH THE PROCEDURES ARE TO BE APPLIED . THE COMPETENT AUTHORITIES SHALL DETERMINE BOTH THE CONDITIONS TO BE FULFILLED FOR AUTHORIZATION FOR SUCH USE TO BE GRANTED AND THE IMPLEMENTING PROCEDURES THEREFOR .  THE SAID AUTHORIZATION MAY BE LIMITED TO CERTAIN GOODS . IT MAY BE GRANTED ON AN OCCASIONAL OR A PERMANENT BASIS . IT MAY BE REVOKED .  3 . USE OF THE PROCEDURES LAID DOWN IN ARTICLES 16 TO 20 SHALL NOT PRECLUDE THE EXERCISE BY THE CUSTOMS AUTHORITY OF ANY CONTROLS WHICH IT CONSIDERS NECESSARY IN ORDER TO ENSURE THAT THE OPERATIONS ARE CORRECTLY CARRIED OUT .  4 . IN THE CASE OF THE SIMPLIFIED PROCEDURES REFERRED TO IN ARTICLES 17 TO 20 , AND WITHOUT PREJUDICE TO ARTICLE 13 , MEMBER STATES MAY , WHERE THEY CONSIDER IT NECESSARY , STIPULATE THAT THEIR CUSTOMS AUTHORITIES MAKE AUTHORIZATION OF THEIR USE CONDITIONAL ON THE LODGING OF A SECURITY DESIGNED TO ENSURE THAT THE BENEFICIARY FULFILS THE OBLIGATIONS IMPOSED ON HIM UNDER THE FIRST SUBPARAGRAPH OF PARAGRAPH 2 .  5 . SAVE AS OTHERWISE PROVIDED IN ARTICLES 16 TO 20 , TITLE I SHALL APPLY TO THE SIMPLIFIED PROCEDURES LAID DOWN IN THESE ARTICLES .  A . EXEMPTION FROM WRITTEN DECLARATION  ARTICLE 16  1 . WITHOUT PREJUDICE TO THE SPECIAL PROVISIONS LAID DOWN IN RESPECT OF CONSIGNMENTS SENT BY PARCEL OR LETTER POST , MEMBER STATES MAY SPECIFY THAT A WRITTEN DECLARATION IS NOT REQUIRED FOR GOODS EXPORTED FOR NON-COMMERCIAL PURPOSES AND GOODS OF LOW VALUE , INCLUDING THOSE CONTAINED IN TRAVELLERS' PERSONAL LUGGAGE .  2 . PARAGRAPH 1 SHALL NOT APPLY TO GOODS FOR WHICH AN EXPORT LICENCE IS REQUIRED OR EXPORT REFUNDS OR OTHER EXPORT PAYMENTS ARE REQUESTED .  B . DRAWING UP OF GENERAL , PERIODIC OR RECAPITULATIVE DECLARATIONS  ARTICLE 17  1 . WITHOUT PREJUDICE TO ARTICLE 20 , THE COMPETENT AUTHORITIES MAY AUTHORIZE THE DECLARANT TO FURNISH OR TO INSERT AT A LATER DATE CERTAIN PARTICULARS OF THE DECLARATION IN THE FORM OF SUPPLEMENTARY DECLARATIONS OF A GENERAL , PERIODIC OR RECAPITULATIVE NATURE .  2 . STATEMENTS MADE IN SUPPLEMENTARY DECLARATIONS , TOGETHER WITH STATEMENTS MADE IN THE DECLARATIONS TO WHICH THEY REFER , SHALL BE DEEMED TO CONSTITUTE A SINGLE , INDIVISIBLE INSTRUMENT TAKING EFFECT AT THE DATE ON WHICH THE CORRESPONDING INITIAL DECLARATION WAS ACCEPTED .  3 . WHERE THE PROCEDURE PROVIDED FOR IN THIS ARTICLE IS INVOKED , THE INITIAL DECLARATIONS RELATING TO EACH BATCH OF GOODS SHALL IN ALL CASES CONTAIN THE PARTICULARS NECESSARY FOR THE IDENTIFICATION OF THE GOODS IN QUESTION .  C . GRANTING OF EXPORT AUTHORIZATION BEFORE THE LODGING OF THE ENTRY  ARTICLE 18  1 . WHERE CIRCUMSTANCES SO JUSTIFY , THE COMPETENT AUTHORITIES MAY AUTHORIZE EXPORT OF THE GOODS AS SOON AS THEY HAVE BEEN PRODUCED , WITHIN THE MEANING OF ARTICLE 5 ( 3 ) , AT THE COMPETENT CUSTOMS OFFICE , WITHOUT THE ENTRY REFERRED TO IN ARTICLE 3 HAVING BEEN LODGED .  2 . AUTHORIZATION TO EXPORT THE GOODS SHALL BE CONDITIONAL ON THE PRESENTATION AT THE COMPETENT CUSTOMS OFFICE OF A COMMERCIAL OR ADMINISTRATIVE DOCUMENT , AT THE DISCRETION OF THE COMPETENT AUTHORITIES , CONTAINING THE PARTICULARS NECESSARY FOR THE IDENTIFICATION OF THE GOODS AND ACCOMPANIED BY AN EXPORT APPLICATION , SIGNED BY THE PERSON CONCERNED .  WHERE APPLICATION OF THE COMMUNITY MEASURES TO WHICH THE EXPORT OF GOODS IN QUESTION GIVES RISE IS SUBJECT TO THE PRESENTATION OF ANY OTHER DOCUMENT , THAT DOCUMENT SHALL ACCOMPANY THE SAID COMMERCIAL OR ADMINISTRATIVE DOCUMENT .  ACCEPTANCE BY THE CUSTOMS OFFICE OF THAT COMMERCIAL OR ADMINISTRATIVE DOCUMENT SHALL HAVE THE SAME FORCE IN LAW AS ACCEPTANCE OF THE DECLARATION REFERRED TO IN ARTICLE 3 .  3 . WHEN CIRCUMSTANCES SO PERMIT , THE COMPETENT AUTHORITIES MAY AGREE TO THE REPLACEMENT OF THE APPLICATION REFERRED TO IN PARAGRAPH 2 BY A GENERAL APPLICATION COVERING EXPORTS TO BE CARRIED OUT DURING A SPECIFIC PERIOD . REFERENCE TO THE AUTHORIZATION GRANTED AS A RESULT OF THIS GENERAL APPLICATION SHALL BE MADE IN THE COMMERCIAL OR ADMINISTRATIVE DOCUMENT TO BE PRESENTED FOR EACH EXPORT IN ACCORDANCE WITH THE FIRST SUBPARAGRAPH OF PARAGRAPH 2 .  4 . THE CUSTOMS AUTHORITY MAY MAKE THE AUTHORIZATION TO EXPORT THE GOODS CONDITIONAL ON THEIR EXAMINATION BASED ON THE PARTICULARS CONTAINED IN THE COMMERCIAL OR ADMINISTRATIVE DOCUMENT REFERRED TO IN PARAGRAPH 2 .  5 . THE DECLARATION RELATING TO THE GOODS COVERED BY THE AUTHORIZATION REFERRED TO IN PARAGRAPH 1 SHALL BE LODGED AT THE COMPETENT CUSTOMS OFFICE WITHIN THE TIME LIMIT LAID DOWN BY THE COMPETENT AUTHORITIES .  FOR THE PURPOSES OF APPLYING ARTICLE 11 , THIS DECLARATION SHALL TAKE EFFECT ON THE DATE ON WHICH THE CUSTOMS AUTHORITY ACCEPTS THE COMMERCIAL OR ADMINISTRATIVE DOCUMENT REFERRED TO IN PARAGRAPH 2 .  6 . WITHOUT PREJUDICE TO ARTICLE 20 , THE CUSTOMS AUTHORITY MAY ALLOW THE LODGING OF GENERAL , PERIODIC OR RECAPITULATIVE DECLARATIONS FOR THE GOODS . SUCH DECLARATIONS SHALL TAKE EFFECT ON THE DATE ON WHICH THAT AUTHORITY ACCEPTED THE COMMERCIAL OR ADMINISTRATIVE DOCUMENT REFERRED TO IN PARAGRAPH 2 .  ARTICLE 19  1 . THE COMPETENT AUTHORITIES MAY AUTHORIZE NATURAL OR LEGAL PERSONS WHO FREQUENTLY EXPORT GOODS TO SEND SUCH GOODS OUT OF THE CUSTOMS TERRITORY OF THE COMMUNITY DIRECTLY FROM THEIR PREMISES , WITHOUT FIRST LODGING THE DECLARATION REFERRED TO IN ARTICLE 3 AT THE COMPETENT CUSTOMS OFFICE .  2 . BEFORE THE GOODS LEAVE HIS PREMISES , THE AUTHORIZED PERSON REFERRED TO IN PARAGRAPH 1 SHALL :   ( A ) GIVE THE COMPETENT AUTHORITIES DUE NOTICE OF DISPATCH , IN THE FORM AND MANNER LAID DOWN BY THEM , FOR THE PURPOSE OF OBTAINING AUTHORIZATION TO EXPORT THE GOODS IN QUESTION ;   ( B ) ENTER THE SAID GOODS IN HIS RECORDS . THIS SHALL BE DONE IN THE FORM AND MANNER LAID DOWN BY THE COMPETENT AUTHORITIES . THIS ENTRY SHALL INCLUDE THE DATE OF ENTRY IN THE RECORDS AND THE PARTICULARS NECESSARY FOR IDENTIFICATION OF THE GOODS ;   ( C ) MAKE AVAILABLE TO THE COMPETENT AUTHORITIES ALL DOCUMENTS , IN PARTICULAR EXPORT LICENCES OR ADVANCE-FIXING CERTIFICATES , THE PRODUCTION OF WHICH MAY BE REQUIRED FOR APPLICATION OF THE PROVISIONS GOVERNING EXPORT OF THE GOODS .  COMPLETION OF THE FORMALITIES REFERRED TO IN SUBPARAGRAPHS ( A ) AND ( B ) SHALL HAVE THE SAME FORCE IN LAW AS ACCEPTANCE OF THE DECLARATION REFERRED TO IN ARTICLE 3 .  3 . PROVIDED THAT CHECKING ON THE REGULARITY OF TRANSACTIONS IS NOT THEREBY AFFECTED , THE COMPETENT AUTHORITIES MAY , IN CERTAIN SPECIAL CIRCUMSTANCES JUSTIFIED BY THE NATURE OF THE GOODS IN QUESTION AND THE INCREASED RATE OF EXPORT , EXEMPT THE AUTHORIZED PERSON FROM THE OBLIGATION TO NOTIFY THE COMPETENT CUSTOMS OFFICE OF EACH DISPATCH OF GOODS , ON CONDITION THAT HE PROVIDES THAT OFFICE WITH ALL THE INFORMATION WHICH IT DEEMS NECESSARY TO ENABLE IT TO EXERCISE , WHERE APPROPRIATE , ITS RIGHT TO EXAMINE THE GOODS . IN THAT CASE , ENTRY OF THE GOODS IN THE RECORDS OF THE PERSON CONCERNED SHALL BE EQUIVALENT TO AUTHORIZATION OF THEIR EXPORT .  4 . WHERE THE CUSTOMS OFFICE DECIDES TO EXAMINE THE GOODS , SUCH EXAMINATION SHALL TAKE PLACE ON THE BASIS OF THE PARTICULARS CONTAINED IN THE RECORDS OF THE PERSON CONCERNED .  5 . THE DECLARATION RELATING TO THE GOODS WHICH ARE THE SUBJECT OF THE AUTHORIZATION REFERRED TO IN PARAGRAPH 1 SHALL BE LODGED AT THE COMPETENT CUSTOMS OFFICE WITHIN THE TIME LIMITS FIXED BY THE COMPETENT AUTHORITIES .  FOR THE PURPOSES OF APPLYING ARTICLE 11 , THIS DECLARATION SHALL TAKE EFFECT ON THE DATE ON WHICH THE GOODS ARE ENTERED IN THE RECORDS OF THE PERSON CONCERNED .  6 . ARTICLE 18 ( 6 ) SHALL ALSO APPLY WHERE THE PROVISIONS OF THIS ARTICLE ARE INVOKED .  7 . THE ENTRY OF THE GOODS IN THE RECORDS OF THE PERSON CONCERNED AS PROVIDED FOR IN PARAGRAPH 2 ( B ) , MAY BE REPLACED BY ANY OTHER FORMALITY OFFERING SIMILAR GUARANTEES WHICH MAY BE LAID DOWN BY THE COMPETENT AUTHORITIES .  D . REPLACEMENT OF ALL OR PART OF THE PARTICULARS OF THE DECLARATION BY CODIFIED DATA  ARTICLE 20  1 . THE COMPETENT AUTHORITIES MAY AUTHORIZE THE DECLARANT TO REPLACE ALL OR PART OF THE PARTICULARS OF THE WRITTEN DECLARATION REFERRED TO IN ARTICLE 3 BY SENDING TO THE CUSTOMS OFFICE DESIGNATED FOR THAT PURPOSE , WITH A VIEW TO THEIR PROCESSING BY COMPUTER , CODIFIED DATA OR DATA MADE OUT IN ANY OTHER FORM SPECIFIED BY THOSE AUTHORITIES , CORRESPONDING TO THE PARTICULARS REQUIRED FOR WRITTEN DECLARATIONS .  2 . THE COMPETENT AUTHORITES SHALL DETERMINE THE CONDITIONS UNDER WHICH THE DATA REFERRED TO IN PARAGRAPH 1 ARE TO BE SENT .  TITLE III  FINAL PROVISIONS  ARTICLE 21  1 . THE COMMITTEE ON GENERAL CUSTOMS RULES PROVIDED FOR IN ARTICLE 24 OF COUNCIL DIRECTIVE 79/695/EEC OF 24 JULY 1979 ON THE HARMONIZATION OF PROCEDURES FOR THE RELEASE OF GOODS FOR FREE CIRCULATION ( 6 ) MAY EXAMINE ANY QUESTION CONCERNING THE APPLICATION OF THIS DIRECTIVE WHICH IS RAISED BY ITS CHAIRMAN EITHER ON HIS OWN INITIATIVE OR AT THE REQUEST OF A REPRESENTATIVE OF A MEMBER STATE .  2 . THE PROVISIONS REQUIRED FOR APPLYING ARTICLES 3 TO 9 , ARTICLE 10 ( 1 ) , ARTICLE 13 , ARTICLE 14 ( 2 ) AND ARTICLES 17 TO 20 OF THIS DIRECTIVE SHALL BE ADOPTED IN ACCORDANCE WITH THE PROCEDURE LAID DOWN IN ARTICLE 26 ( 2 ) AND ( 3 ) OF DIRECTIVE 79/695/EEC .  ARTICLE 22  1 . MEMBER STATES SHALL TAKE THE MEASURES NECESSARY TO COMPLY WITH THIS DIRECTIVE NOT LATER THAN 1 JANUARY 1983 .  2 . EACH MEMBER STATE SHALL INFORM THE COMMISSION OF THE MEASURES WHICH IT ADOPTS FOR THE PURPOSES OF IMPLEMENTING THIS DIRECTIVE . THE COMMISSION SHALL COMMUNICATE THIS INFORMATION TO THE OTHER MEMBER STATES .  ARTICLE 23  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 24 FEBRUARY 1981 .  FOR THE COUNCIL  THE PRESIDENT  G . BRAKS  ( 1 ) OJ NO C 34 , 11 . 2 . 1980 , P . 116 .  ( 2 ) OJ NO C 83 , 2 . 4 . 1980 , P . 10 .  ( 3 ) OJ NO L 183 , 14 . 7 . 1975 , P . 3 .  ( 4 ) OJ NO L 323 , 29 . 11 . 1980 , P . 27 .  ( 5 ) OJ NO L 146 , 2 . 6 . 1978 , P . 19 .  ( 6 ) OJ NO L 205 , 13 . 8 . 1979 , P . 19 .