Avis juridique important

|

31992L0028

Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use

Official Journal L 113 , 30/04/1992 P. 0013 - 0018 Finnish special edition: Chapter 15 Volume 11 P. 0040  Swedish special edition: Chapter 15 Volume 11 P. 0040

COUNCIL DIRECTIVE 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human useTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,  Having regard to the proposal from the Commission(1) ,  In cooperation with the European Parliament(2) ,  Having regard to the opinion of the Economic and Social Committee(3) ,  Whereas Directive 84/450/EEC(4)  harmonized the laws, regulations and administrative provisions of the Member States concerning misleading advertising; whereas this Directive is without prejudice to the application of measures adopted pursuant to that  Directive;  Whereas all Member States have adopted further specific measures concerning the advertising of medicinal products; whereas there are disparities between these measures; whereas these disparities are likely to have an impact on the establishment and  functioning of the internal market, since advertising disseminated in one Member State is likely to have effects in other Member States;  Whereas Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the pursuit of television broadcasting activities(5)  prohibits the  television advertising of medicinal products which are available only on medical prescription in the Member State within whose jurisdiction the television broadcaster is located; whereas this principle should be made of general application by extending  it to other media;  Whereas advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered; whereas advertising of medicinal products to the general public, where it is permitted, ought  therefore to satisfy certain essential criteria which ought to be defined;  Whereas, furthermore, distribution of samples free of charge to the general public for promotional ends must be prohibited;  Whereas the advertising of medicinal products to persons qualified to prescribe or supply them contributes to the information available to such persons; whereas, nevertheless, this advertising should be subject to strict conditions and effective  monitoring, referring in particular to the work carried out within the framework of the Council of Europe;  Whereas medical sales representatives have an important role in the promotion of medicinal products; whereas, therefore, certain obligations should be imposed upon them, in particular the obligation to supply the person visited with a summary of product  characteristics;  Whereas persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements;  Whereas it should be possible within certain restrictive conditions to provide samples of medicinal products free of charge to persons qualified to prescribe or supply them so that they can familiarize themselves with new products and acquire experience  in dealing with them;  Whereas persons qualified to prescribe or supply medicinal products must have access to a neutral, objective source of information about products available on the market; whereas it is nevertheless for the Member States to take all measures necessary to  this end, in the light of their own particular situation;  Whereas advertising of medicinal products should be subject to effective, adequate monitoring; whereas reference in this regard should be made to the monitoring mechanisms set up by Directive 84/450/EEC;  Whereas each undertaking which manufactures or imports medicinal products should set up a mechanism to ensure that all information supplied about a medicinal product conforms with the approved conditions of use,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I Scope, definitions and general principles   Article 1  1.  This Directive concerns the advertising in the Community of medicinal products for human use covered by Chapters II to V of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or  administrative action relating to medicinal products(6) .  2.  For the purposes of this Directive:  - the definitions of the name of the medicinal product and of the common name shall be those laid down in Article 1 of Directive 92/27/EEC(7) ;  - the summary of product characteristics shall be the summary approved by the competent authority which granted the marketing authorization in accordance with Article 4b of Directive 65/65/EEC.  3.  For the purposes of this Directive, advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it  shall include in particular:  - the advertising of medicinal products to the general public,  - advertising of medicinal products to persons qualified to prescribe or supply them,  - visits by medical sales representatives to persons qualified to prescribe medicinal products,  - the supply of samples,  - the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,  - sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,  - sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith.  4.  The following are not covered by this Directive:  - the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of Directive 92/27/EEC;  - correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;  - factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;  - statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.  Article 2  1.  Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorization has not been granted in accordance with Community law.  2.  All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.  3.  The advertising of a medicinal product:  - shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,  - shall not be misleading.  CHAPTER II Advertising to the general public   Article 3  1.  Member States shall prohibit the advertising to the general public of medicinal products which:  - are available on medical prescription only, in accordance with Directive 92/26/EEC(8) ,  - contain psychotropic or narcotic substances, within the meaning of the international conventions,  - may not be advertised to the general public in accordance with paragraph 2.  2.  Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the invervention of a medical practitioner for diagnostic purposes or for the prescription or  monitoring of treatment, with the advice of the pharmacist, if necessary.  Member States shall prohibit the mentioning in advertising to the general public of therapeutic indications such as:  - tuberculosis,  - sexually transmitted diseases,  - other serious infectious diseases,  - cancer and other tumoral diseases,  - chronic insomnia,  - diabetes and other metabolic illnesses.  3.  Member States shall also be able to ban on their territory advertising to the general public of medicinal products the cost of which may be reimbursed.  4.  The prohibition referred to in paragraph 1 shall not apply to vaccination campaigns carried out by the industry and approved by the competent authorities of the Member States.  5.  The prohibition referred to in paragraph 1 shall apply without prejudice to Articles 2, 3 and 14 of Directive 89/552/EEC.  6.  Member States shall prohibit the direct distribution of medicinal products to the public by the industry for promotional purposes; they may, however, authorize such distribution in special cases for other purposes.  Article 4  1.  Without prejudice to Article 3, all advertising to the general public of a medicinal product shall:  (a) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a medicinal product;  (b) include the following minimum information:  - the name of the medicinal product, as well as the common name if the medicinal product contains only one active ingredient,  - the information necessary for correct use of the medicinal product,  - an express, legible invitation to read carefully the instructions on the package leaflet or on the outer packaging, according to the case.  2.  Member States may decide that the advertising of a medicinal product to the general public may, notwithstanding paragraph 1, include only the name of the medicinal product if it is intended solely as a reminder.  Article 5  The advertising of a medicinal product to the general public shall not contain any material which:  (a) gives the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail;  (b) suggests that the effects of taking the medicine are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another treatment or medicinal product;  (c) suggests that the health of the subject can be enhanced by taking the medicine;  (d) suggests that the health of the subject could be affected by not taking the medicine; this prohibition shall not apply to the vaccination campaigns referred to in Article 3 (4);  (e) is directed exclusively or principally at children;  (f) refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;  (g) suggests that the medicinal product is a foodstuff, cosmetic or other consumer product;  (h) suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural;  (i) could, by a description or detailed representation of a case history, lead to erroneous self diagnosis;  (j) refers, in improper, alarming or misleading terms, to claims of recovery;  (k) uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts thereof;  (l) mentions that the medicinal product has been granted a marketing authorization.  CHAPTER III Advertising to health professionals   Article 6  1.  Any advertising of a medicinal product to persons qualified to prescribe or supply such products shall include:  - essential information compatible with the summary of product characteristics;  - the supply classification of the medicinal product.  Member States may also require such advertising to include the selling price or indicative price of the various presentations and the conditions for reimbursement by social security bodies.  2.  Member States may decide that the advertising of a medicinal product to persons qualified to prescribe or supply such products may, notwithstanding paragraph 1, include only the name of the medicinal product, if it is intended solely as a reminder.   Article 7  1.  Any documentation relating to a medicinal product which is transmitted as part of the promotion of that product to persons qualified to prescribe or supply it shall include as a minimum the particulars listed in Article 6 (1) and shall  state the date on which it was drawn up or last revised.  2.  All the information contained in the documentation referred to in paragraph 1 shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal  product concerned.  3.  Quotations as well as tables and other illustrative matter taken from medical journals or other scientific works for use in the documentation referred to in paragraph 1 shall be faithfully reproduced and the precise sources indicated.  Article 8  1.  Medical sales representatives shall be given adequate training by the firm which employs them and shall have sufficient scientific knowledge to be able to provide information which is precise and as complete as possible about the  medicinal products which they promote.  2.  During each visit, medical sales representatives shall give the persons visited, or have available for them, summaries of the product characteristics of each medicinal product they present together, if the legislation of the Member State so permits,  with details of the price and conditions for reimbursement referred to in Article 6 (1).  3.  Medical sales representatives shall transmit to the scientific service referred to in Article 13 (1) any information about the use of the medicinal products they advertise, with particular reference to any adverse reactions reported to them by the  persons they visit.  Article 9  1.  Where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant  to the practice of medicine or pharmacy.  2.  Hospitality at sales promotion must always be reasonable in level and secondary to the main purpose of the meeting and must not be extended to other than health professionals.  3.  Persons qualified to prescribe or supply medicinal products shall not solicit or accept any inducement prohibited under paragraph 1 or contrary to paragraph 2.  4.  Existing measures or trade practices in Member States relating to prices, margins and discounts shall not be affected by this Article.  Article 10  The provisions of Article 9 (1) shall not prevent hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes; such hospitality must always be reasonable in level and remain subordinate to the  main scientific objective of the meeting; it must not be extended to persons other than health professionals.  Article 11  1.  Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:  (a) a limited number of samples for each medicinal product each year on prescription;  (b) any supply of samples must be in response to a written request, signed and dated, from the recipient;  (c) those supplying samples must maintain an adequate system of control and accountability;  (d) each sample shall be identical with the smallest presentation on the market;  (e) each sample shall be marked free medical sample - not for resale or bear another legend of analogous meaning;  (f) each sample shall be accompanied by a copy of the summary of product characteristics;  (g) no samples of medicinal products containing psychotropic or narcotic substances within the meaning of international conventions may be supplied.  2.  Member States may also place further restrictions on the distribution of samples of certain medicinal products.  CHAPTER IV Monitoring of advertising   Article 12  1.  Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under  which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Directive may take legal action against such advertisement, or bring such advertisement before an  administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings.  2.  Under the legal provisions referred to in paragraph 1, Member States shall confer upon the courts or administrative authorities powers enabling them, in cases where they deem such measures to be necessary taking into account all the interests  involved and in particular the public interest:  - to order the cessation of, or to institute appropriate legal proceedings for an order for the cessation of, misleading advertising,  or - if misleading advertising has not yet been published but publication is imminent, to order the prohibition of, or to institute appropriate legal proceedings for an order for the prohibition of, such publication,  even without proof of actual loss or damage or of intention or negligence on the part of the advertiser.  Member States shall also make provision for the measures referred to in the first subparagraph to be taken under an accelerated procedure:  - either with interim effect, or - with definitive effect,  on the understanding that it is for each Member State to decide which of the two options to select.  Furthermore, Member States may confer upon the courts or administrative authorities powers enabling them, with a view to eliminating the continuing effects of misleading advertising the cessation of which has been ordered by a final decision:  - to require publication of that decision in full or in part and in such form as they deem adequate,  - to require in addition the publication of a corrective statement.  3.  Under the legal provisions referred to in paragraph 1, Member States shall ensure that any decision taken in accordance with paragraph 2 shall state in detail the reasons on which it is based and shall be communicated in writing to the person  concerned, mentioning the redress available at law and the time limit allowed for access to such redress.  4.  This Article shall not exclude the voluntary control of advertising of medicinal products by self-regulatory bodies and recourse to such bodies, if proceedings before such bodies are possible in addition to the judicial or administrative proceedings  referred to in paragraph 1.  Article 13  1.  The marketing authorization holder shall establish within his undertaking a scientific service in charge of information about the medicinal products which he places on the market.  2.  The person responsible for placing the product on the market shall:  - keep available for, or communicate to, the authorities or bodies responsible for monitoring advertising of medicinal products a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is  addressed, the method of dissemination and the date of first dissemination,  - ensure that advertising of medicinal products by his undertaking conforms to the requirements of this Directive,  - verify that medical sales representatives employed by his undertaking have been adequately trained and fulfill the obligations imposed upon them by Article 8 (2) and (3),  - supply the authorities or bodies responsible for monitoring advertising of medicinal products with the information and assistance they require to carry out their responsibilities,  - ensure that the decisions taken by the authorities or bodies responsible for monitoring advertising of medicinal products are immediately and fully complied with.  Article 14  Member States shall take the appropriate measures to ensure that all the provisions of this Directive are applied in full and shall determine in particular what penalties shall be imposed should the provisions adopted in the execution of  this Directive be infringed.  Article 15  1.  Member States shall take the measures necessary in order to comply with this Directive with effect from 1 January 1993. They shall forthwith inform the Commission thereof.  2.  When Member States adopt the said measures, such measures shall contain a reference to this Directive or 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.  Article 16  This Directive is addressed to the Member States.  Done at Brussels, 31 March 1992.  For the Council The President Vitor MARTINS    (1) OJ No C 163, 4. 7. 1990, p. 10 and OJ No C 207, 8. 8. 1991, p. 25.  (2) OJ No C 183, 15. 7. 1991, p. 227 and OJ No C 67, 16. 3. 1992.  (3) OJ No C 60, 8. 3. 1991, p. 40.  (4) OJ No L 250, 19. 9. 1984, p. 17.  (5) OJ No L 298, 17. 10. 1989, p. 23.  (6) OJ No 22, 9. 2. 1965, p. 369/65. Directive last amended by Directive 89/341/EEC (OJ No L 142, 25. 5. 1989, p. 11).  (7) See page 8 of this Official Journal.  (8) See page 5 of this Official Journal.


title: Commission Directive 2009/97/EC of 3 August 2009 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species (Text with EEA relevance)

text:
               4.8.2009

               EN

               Official Journal of the European Union

               L 202/29

      COMMISSION DIRECTIVE 2009/97/EC
   of 3 August 2009
   amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,
   Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (2), and in particular Article 7(2)(a) and (b) thereof,
   Whereas:

               (1)

               Commission Directives 2003/90/EC (3) and 2003/91/EC (4) were adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties those Directives provide that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply.

               (2)

               The CPVO has since established further guidelines for a number of other species, and has updated existing ones.

               (3)

               As regards Directive 2003/90/EC, guidelines have to be added for new species which have recently been included in the lists of species covered by Directives 66/401/EEC (5) and 66/402/EEC (6).

               (4)

               Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and II to Directive 2003/90/EC are replaced by the text in part A of the Annex to this Directive.
   Article 2
   The Annexes to Directive 2003/91/EC are replaced by the text in part B of the Annex to this Directive.
   Article 3
   For examinations started before 1 January 2010 Member States may apply Directives 2003/90/EC and 2003/91/EC in the version applying before their amendment by this Directive.
   Article 4
   Member States shall adopt and publish, by 31 December 2009 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 January 2010.
   When Member States adopt those 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.
   Article 5
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 3 August 2009.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 193, 20.7.2002, p. 1.

      (2)  OJ L 193, 20.7.2002, p. 33.

      (3)  OJ L 254, 8.10.2003, p. 7.

      (4)  OJ L 254, 8.10.2003, p. 11.

      (5)  OJ 125, 11.7.1966, p. 2298/66.

      (6)  OJ 125, 11.7.1966, p. 2309/66.

      ANNEX

         PARTE A

      ‘
            ANNEX I

               List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Pisum sativum L.

                        Field pea

                        TP 7/1 of 6.11.2003

                           Vicia faba L.

                        Field bean

                        TP Broadbean/1 of 25.3.2004

                           Brassica napus L.

                        Swede rape

                        TP 36/1 of 25.3.2004

                           Helianthus annuus L.

                        Sunflower

                        TP 81/1 of 31.10.2002

                           Linum usitatissimum L.

                        Flax/Linseed

                        TP 57/1 of 21.3.2007

                           Avena nuda L.

                        Small naked oat, Hulless oat

                        TP 20/1 of 6.11.2003

                           Avena sativa L. (includes A. byzantina K. Koch)

                        Oats and Red oat

                        TP 20/1 of 6.11.2003

                           Hordeum vulgare L.

                        Barley

                        TP 19/2 of 6.11.2003

                           Oryza sativa L.

                        Rice

                        TP 16/1 of 18.11.2004

                           Secale cereale L.

                        Rye

                        TP 58/1 of 31.10.2002

                           xTriticosecale Wittm. ex A. Camus

                        Hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale

                        TP 121/2 of 22.1.2007

                           Triticum aestivum L.

                        Wheat

                        TP 3/4 of 23.6.2008

                           Triticum durum Desf.

                        Durum wheat

                        TP 120/2 of 6.11.2003

                           Zea mays L.

                        Maize

                        TP 2/2 of 15.11.2001

                           Solanum tuberosum L.

                        Potato

                        TP 23/2 of 1.12.2005

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II

               List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Fodder beet

                        TG/150/3 of 4.11.1994

                           Agrostis canina L.

                        Velvet bent

                        TG/30/6 of 12.10.1990

                           Agrostis gigantea Roth.

                        Red top

                        TG/30/6 of 12.10.1990

                           Agrostis stolonifera L.

                        Creeping bent

                        TG/30/6 of 12.10.1990

                           Agrostis capillaris L.

                        Brown top

                        TG/30/6 of 12.10.1990

                           Bromus catharticus Vahl

                        Rescue grass

                        TG/180/3 of 4.4.2001

                           Bromus sitchensis Trin.

                        Alaska brome grass

                        TG/180/3 of 4.4.2001

                           Dactylis glomerata L.

                        Cocksfoot

                        TG/31/8 of 17.4.2002

                           Festuca arundinacea Schreber

                        Tall fescue

                        TG/39/8 of 17.4.2002

                           Festuca filiformis Pourr.

                        Fine-leaved sheep’s fescue

                        TG/67/5 of 5.4.2006

                           Festuca ovina L.

                        Sheep’s fescue

                        TG/67/5 of 5.4.2006

                           Festuca pratensis Huds.

                        Meadow fescue

                        TG/39/8 of 17.4.2002

                           Festuca rubra L.

                        Red fescue

                        TG/67/5 of 5.4.2006

                           Festuca trachyphylla (Hack.) Krajina

                        Hard fescue

                        TG/67/5 of 5.4.2006

                           Lolium multiflorum Lam.

                        Italian ryegrass

                        TG/4/8 of 5.4.2006

                           Lolium perenne L.

                        Perennial ryegrass

                        TG/4/8 of 5.4.2006

                           Lolium x boucheanum Kunth

                        Hybrid ryegrass

                        TG/4/8 of 5.4.2006

                           Phleum nodosum L.

                        Small timothy

                        TG/34/6 of 7.11.1984

                           Phleum pratense L.

                        Timothy

                        TG/34/6 of 7.11.1984

                           Poa pratensis L.

                        Smooth-stalked meadow grass

                        TG/33/6 of 12.10.1990

                           Lupinus albus L.

                        White lupin

                        TG/66/4 of 31.3.2004

                           Lupinus angustifolius L.

                        Narrow-leaved lupin

                        TG/66/4 of 31.3.2004

                           Lupinus luteus L.

                        Yellow lupin

                        TG/66/4 of 31.3.2004

                           Medicago sativa L.

                        Lucerne

                        TG/6/5 of 6.4.2005

                           Medicago x varia T. Martyn

                        Sand lucerne

                        TG/6/5 of 6.4.2005

                           Trifolium pratense L.

                        Red clover

                        TG/5/7 of 4.4.2001

                           Trifolium repens L.

                        White clover

                        TG/38/7 of 9.4.2003

                           Vicia sativa L.

                        Common vetch

                        TG/32/6 of 21.10.1988

                           Brassica napus L. var. napobrassica (L.) Rchb.

                        Swede

                        TG/89/6 of 4.4.2001

                           Raphanus sativus L. var. oleiformis Pers.

                        Fodder radish

                        TG/178/3 of 4.4.2001

                           Arachis hypogea L.

                        Groundnut/Peanut

                        TG/93/3 of 13.11.1985

                           Brassica rapa L. var. silvestris (Lam.) Briggs

                        Turnip rape

                        TG/185/3 of 17.4.2002

                           Carthamus tinctorius L.

                        Safflower

                        TG/134/3 of 12.10.1990

                           Gossypium spp.

                        Cotton

                        TG/88/6 of 4.4.2001

                           Papaver somniferum L.

                        Poppy

                        TG/166/3 of 24.3.1999

                           Sinapis alba L.

                        White mustard

                        TG/179/3 of 4.4.2001

                           Glycine max (L.) Merrill

                        Soya bean

                        TG/80/6 of 1.4.1998

                           Sorghum bicolor (L.) Moench

                        Sorghum

                        TG/122/3 of 6.10.1989

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’

         PARTE B

      ‘
            ANNEX I

               List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Allium cepa L. (Cepa group)

                        Onion and Echalion

                        TP 46/2 of 1.4.2009

                           Allium cepa L. (Aggregatum group)

                        Shallot

                        TP 46/2 of 1.4.2009

                           Allium porrum L.

                        Leek

                        TP 85/2 of 1.4.2009

                           Allium sativum L.

                        Garlic

                        TP 162/1 of 25.3.2004

                           Allium schoenoprasum L.

                        Chives

                        TP 198/1 of 1.4.2009

                           Apium graveolens L.

                        Celery

                        TP 82/1 of 13.3.2008

                           Apium graveolens L.

                        Celeriac

                        TP 74/1 of 13.3.2008

                           Asparagus officinalis L.

                        Asparagus

                        TP 130/1 of 27.3.2002

                           Beta vulgaris L.

                        Beetroot including Cheltenham beet

                        TP 60/1 of 1.4.2009

                           Brassica oleracea L.

                        Cauliflower

                        TP 45/1 of 15.11.2001

                           Brassica oleracea L.

                        Sprouting broccoli or Calabrese

                        TP 151/2 of 21.3.2007

                           Brassica oleracea L.

                        Brussels sprouts

                        TP 54/2 of 1.12.2005

                           Brassica oleracea L.

                        Kohlrabi

                        TP 65/1 of 25.3.2004

                           Brassica oleracea L.

                        Savoy cabbage, White cabbage and Red cabbage

                        TP 48/2 of 1.12.2005

                           Brassica rapa L.

                        Chinese cabbage

                        TP 105/1 of 13.3.2008

                           Capsicum annuum L.

                        Chilli or Pepper

                        TP 76/2 of 21.3.2007

                           Cichorium endivia L.

                        Curled-leaved endive and Plain-leaved endive

                        TP 118/2 of 1.12.2005

                           Cichorium intybus L.

                        Industrial chicory

                        TP 172/2 of 1.12.2005

                           Cichorium intybus L.

                        Witloof chicory

                        TP 173/1 of 25.3.2004

                           Citrullus lanatus (Thumb.) Matsum. et Nakai

                        Watermelon

                        TP 142/1 of 21.3.2007

                           Cucumis melo L.

                        Melon

                        TP 104/2 of 21.3.2007

                           Cucumis sativus L.

                        Cucumber and Gherkin

                        TP 61/2 of 13.3.2008

                           Cucurbita pepo L.

                        Marrow or Courgette

                        TP 119/1 of 25.3.2004

                           Cynara cardunculus L.

                        Globe artichoke and Cardoon

                        TP 184/1 of 25.3.2004

                           Daucus carota L.

                        Carrot and Fodder carrot

                        TP 49/3 of 13.3.2008

                           Foeniculum vulgare Mill.

                        Fennel

                        TP 183/1 of 25.3.2004

                           Lactuca sativa L.

                        Lettuce

                        TP 13/4 of 1.4.2009

                           Lycopersicon esculentum Mill.

                        Tomato

                        TP 44/3 of 21.3.2007

                           Petroselinum crispum (Mill.) Nyman ex A. W. Hill

                        Parsley

                        TP 136/1 of 21.3.2007

                           Phaseolus coccineus L.

                        Runner bean

                        TP 9/1 of 21.3.2007

                           Phaseolus vulgaris L.

                        Dwarf French bean and Climbing French bean

                        TP 12/3 of 1.4.2009

                           Pisum sativum L. (partim)

                        Wrinkled pea, Round pea and Sugar pea

                        TP 7/1 of 6.11.2003

                           Raphanus sativus L.

                        Radish

                        TP 64/1 of 27.3.2002

                           Solanum melongena L.

                        Aubergine or Egg plant

                        TP 117/1 of 13.3.2008

                           Spinacia oleracea L.

                        Spinach

                        TP 55/2 of 13.3.2008

                           Valerianella locusta (L.) Laterr.

                        Corn salad or Lamb’s lettuce

                        TP 75/2 of 21.3.2007

                           Vicia faba L. (partim)

                        Broad bean

                        TP Broadbean/1 of 25.3.2004

                           Zea mays L. (partim)

                        Sweet corn and Pop corn

                        TP 2/2 of 15.11.2001

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II

               List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Scientific name

                        Common name

                        UPOV guideline

                           Allium fistulosum L.

                        Japanese bunching onion or Welsh onion

                        TG/161/3 of 1.4.1998

                           Beta vulgaris L.

                        Spinach beet or Chard

                        TG/106/4 of 31.3.2004

                           Brassica oleracea L.

                        Curly kale

                        TG/90/6 of 31.3.2004

                           Brassica rapa L.

                        Turnip

                        TG/37/10 of 4.4.2001

                           Cichorium intybus L.

                        Large-leaved chicory or Italian chicory

                        TG/154/3 of 18.10.1996

                           Cucurbita maxima Duchesne

                        Gourd

                        TG/155/4 of 28.3.2007

                           Raphanus sativus L.

                        Black radish

                        TG/63/6 of 24.3.1999

                           Rheum rhabarbarum L.

                        Rhubarb

                        TG/62/6 of 24.3.1999

                           Scorzonera hispanica L.

                        Scorzonera or Black salsify

                        TG/116/3 of 21.10.1988

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’


Avis juridique important

|

32004L0031

Commission Directive 2004/31/EC of 17 March 2004 amending Annexes I, II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

Official Journal L 085 , 23/03/2004 P. 0018 - 0023

Commission Directive 2004/31/ECof 17 March 2004amending Annexes I, II, III, IV and V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the CommunityTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,After consulting the Member States concerned,Whereas:(1) From information supplied by Sweden based on surveys, it appears that areas in Sweden should not longer be recognised as "protected zones" in respect of Beet necrotic yellow vein virus.(2) Under Directive 2000/29/EC, the introduction into the Community of plants of Vitis L., other than fruits, originating in third countries is prohibited.(3) From information supplied by Switzerland, it appears that the measures Switzerland applies as regards the introduction into and movement within its territory of plants of Vitis L., other than fruits, are equivalent to the measures laid down in Directive 2000/29/EC. Therefore, plants of Vitis L., other than fruits, originating in Switzerland should be allowed to enter the Community.(4) Under Directive 2000/29/EC, the introduction into the areas within the Community recognised as protected zones as regards Erwinia amylovora (Burr.) Winsl. et al. of the host plants, other than fruit and seeds, of this harmful organism, originating in third countries other than those recognised as being free from this harmful organism, or in which pest free areas have been established in relation to this harmful organism, is prohibited.(5) From information supplied by Switzerland, it appears that the measures Switzerland applies as regards the introduction into and movement within its territory of host plants of Erwinia amylovora (Burr.) Winsl. et al., other than fruits and seeds, are largely equivalent to the measures laid down in Directive 2000/29/EC. Therefore, host plants of Erwinia amylovora (Burr.) Winsl. et al., other than fruits and seeds, and other than plants of Cotoneaster Ehrh. and Photinia davidiana (Dcne.) Cardot, originating in Switzerland should be allowed to enter the Community.(6) From information supplied by Italy based on surveys, it appears that some areas in Italy should not longer be recognised as "protected zones" in respect of Erwinia amylovora (Burr.) Winsl. et al.(7) Due to a clerical error in the preparation of Directive 2003/116/EC, current point 21.1 of Part B of Annex IV to Directive 2000/29/EC was erroneously numbered.(8) The current provisions against Tilletia indica Mitra should be amended to take into account the updated information on the presence of this harmful organism in Iran.(9) Directive 2000/29/EC should therefore be amended accordingly.(10) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annexes I, II, III, IV and V to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 20 April 2004 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 those 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 DirectiveArticle 3This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 17 March 2004.For the CommissionDavid ByrneMember of the Commission(1) OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2003/116/EC (OJ L 321, 6.12.2003, p. 36).ANNEXAnnexes I, II, III, IV and V to Directive 2000/29/EC are amended as follows:1. in Part B of Annex I, under heading (b), point 1 is replaced by the following:">TABLE>"2. in Part B of Annex II, under heading (b), point 2 is replaced by the following:">TABLE>"3. Annex III is amended as follows:(a) in the right-hand column of point 15 of Part A, the text is replaced by the following;"Third countries other than Switzerland";(b) in Part B, point 1 is replaced by the following:">TABLE>"4. Annex IV is amended as follows:(a) Section I of Part A is amended as follows:(i) in the left-hand column of point 53, the text ", Iran" is inserted(ii) in the left-hand column of point 54, the text ", Iran" is inserted;(b) Part B is amended as follows:(i) in the right hand column of point 20.1, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(ii) in the right hand column of point 20.2, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(iii) point 21 is replaced by the following:">TABLE>"(iv) point 21.1 is deleted;(v) a new point 21.3 is inserted before point 22:">TABLE>"(vi) in the right hand column of point 22, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(vii) in the right hand column of point 23, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(viii) in the right hand column of point 25, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(ix) in the right hand column of point 26, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(x) in the right hand column of point 27.1, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(xi) in the right hand column of point 27.2, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)";(xii) in the right hand column of point 30, the text is replaced by the following:"DK, F (Britanny), FI, IRL, P (Azores), UK (Northern Ireland)".5. In point 1 and 8, under heading I of Part B of Annex V, the text ", Iran" is inserted after "India".


Avis juridique important

|

31980L0369

Council Directive 80/369/EEC of 26 March 1980 authorizing the French Republic not to apply in the French overseas departments Directives 72/464/EEC and 79/32/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco

Official Journal L 090 , 03/04/1980 P. 0042 - 0042 Finnish special edition: Chapter 1 Volume 2 P. 0004  Greek special edition: Chapter 09 Volume 1 P. 0121  Swedish special edition: Chapter 1 Volume 2 P. 0004  Spanish special edition: Chapter 09 Volume 1 P. 0126  Portuguese special edition Chapter 09 Volume 1 P. 0126

COUNCIL DIRECTIVE  of 26 March 1980  authorizing the French Republic not to apply in the French overseas departments Directives 72/464/EEC and 79/32/EEC on taxes other than turnover taxes which affect the consumption of manufactured tobacco  (80/369/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof,  Having regard to the proposal from the Commission,  Whereas the third subparagraph of Article 227 (2) of the Treaty requires that the institutions of the Community should, within the framework of the procedure provided for in the Treaty, take care that the economic and social development of the French overseas departments is possible;  Whereas, in accordance with the judgment handed down by the Court of Justice on 10 October 1978 in Case 148/77, the Treaty and secondary legislation apply in the French overseas departments unless a decision is taken by the Community institutions adopting measures particularly suited to the economic and social conditions of those departments;  Whereas, for reasons connected with their geographic economic and social situation, the French Republic should be granted the possibility not to apply in the French overseas departments Community provisions on taxes other than turnover taxes which affect the consumption of manufactured tobacco, as fixed by Council Directives 72/464/EEC (1) and 79/32/EEC (2);  Whereas implementation of this Directive does not involve any amendment of the laws of the Member States,  HAS ADOPTED THIS DIRECTIVE:    Article 1 The following sentence shall be added to Article 12 (1) of Directive 72/464/EEC and to Article 9 (2) of Directive 79/32/EEC:  "The French Republic shall not be obliged to apply the provisions of this Directive in the French overseas departments."   Article 2 This Directive is addressed to the Member States.     Done at Brussels, 26 March 1980.  For the Council  The President  G. MARCORA  (1)OJ No L 303, 31.12.1972, p. 1. (2)OJ No L 10, 16.1.1979, p. 8.