title: Commission Directive 2006/85/EC of 23 October 2006 amending Council Directive 91/414/EEC to include fenamiphos and ethephon as active substances   (Text with EEA relevance)

text:
               24.10.2006

               EN

               Official Journal of the European Union

               L 293/3

      COMMISSION DIRECTIVE 2006/85/EC
   of 23 October 2006
   amending Council Directive 91/414/EEC to include fenamiphos and ethephon as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 703/2001 (3) lay down the detailed rules for the implementation of the second stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes fenamiphos and ethephon.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 703/2001 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 8(1) of Regulation (EC) No 451/2000. For fenamiphos the rapporteur Member State was the Netherlands and all relevant information was submitted on 27 November 2003. For ethephon the rapporteur Member State was the Netherlands and all relevant information was submitted on 21 April 2004.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 13 January 2006 for fenamiphos and on 24 April 2006 for ethephon in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 14 July 2006 in the format of the Commission review reports for fenamiphos and ethephon.

               (4)

               It has appeared from the various examinations made that plant protection products containing fenamiphos and ethephon may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (6)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing fenamiphos and ethephon to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (7)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (8)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (9)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 31 January 2008 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 February 2008.
   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 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fenamiphos and ethephon as active substances by 31 January 2008.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to fenamiphos and ethephon are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fenamiphos and ethephon as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 July 2007 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fenamiphos and ethephon respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing fenamiphos and ethephon as the only active substance, where necessary, amend or withdraw the authorisation by 31 July 2011 at the latest; or

               (b)

               in the case of a product containing fenamiphos and ethephon as one of several active substances, where necessary, amend or withdraw the authorisation by 31 July 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 August 2007.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 23 October 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2006/75/EC (OJ L 248, 12.9.2006, p. 3).

      (2)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

      (3)  OJ L 98, 7.4.2001, p. 6.

      (4)  EFSA Scientific Report (2006) 62, 1-81, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fenamiphos (finalised: 13 January 2006).
   EFSA Scientific Report (2006) 67, 1-61, Conclusion regarding the peer review of the pesticide risk assessment of the active substance ethephon (finalised: 24 April 2006).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC.

                     ‘No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     143

                     Fenamiphos
                     CAS No 22224-92-6
                     CIPAC No 692

                        (RS)-ethyl 4-methylthio-m-tolyl isopropyl-phosphoramidate

                     ≥ 940 g/kg

                     1 August 2007

                     31 July 2017

                     PART A
                     Only uses as nematicide applied by drip irrigation in greenhouses with permanent structure may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenamiphos, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.
                     In this overall assessment:

                                 —

                                 Member States must pay particular attention to the protection of aquatic organisms, soil non-target organisms and groundwater in vulnerable situations.

                           Conditions of authorisation should include risk mitigation measures and monitoring programmes should be initiated to verify potential groundwater contamination in vulnerable zones, where appropriate.

                     144

                     Ethephon
                     CAS No 16672-87-0
                     CIPAC No 373

                     2-chloroethyl-phosphonic acid

                     ≥ 910 g/kg (technical material — TC)
                     The manufacturing impurities MEPHA (Mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid) and 1,2-Dichloroethane are of toxicological concern and must not exceed respectively 20 g/kg and 0,5 g/kg in the technical material.

                     1 August 2007

                     31 July 2017

                     PART A
                     Only uses as plant growth regulator may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account.

         (1)  Further details on identity and specification of active substance are provided in the review report.’


Avis juridique important

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31972L0168

Commission Directive 72/168/EEC of 14 April 1972 on determining the characteristics and minimum conditions for inspecting vegetable varieties

Official Journal L 103 , 02/05/1972 P. 0006 - 0024 Finnish special edition: Chapter 3 Volume 4 P. 0105  Danish special edition: Series I Chapter 1972(II) P. 0348  Swedish special edition: Chapter 3 Volume 4 P. 0105  English special edition: Series I Chapter 1972(II) P. 0363  Greek special edition: Chapter 03 Volume 7 P. 0198  Spanish special edition: Chapter 03 Volume 5 P. 0200  Portuguese special edition Chapter 03 Volume 5 P. 0200

COMMISSION DIRECTIVE of 14 April 1972 on determining the characteristics and minimum conditions for inspecting vegetable varieties (72/168/EEC)    THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community;  Having regard to the Council Directive1 of 29 September 1970 on the marketing of vegetable seed, as amended by the Directive of 30 March 1971,2 and in particular Article 7 (2) thereof;  Whereas, in accordance with the provisions of the abovementioned Directive, Member States are obliged to compile one or more catalogues of the varieties accepted for certification and inspection of standard seed and marketing in their territory;  Whereas the acceptance of varieties is subject to Community conditions which must be enforced by means of official inspections and in particular by crop inspections;  Whereas the inspections must cover a sufficient number of characteristics to enable the varieties to be described;  Whereas the minimum characteristics which have to undergo inspection should be determined at Community level;  Whereas, moreover, the minimum conditions for carrying out the inspections must be laid down;  Whereas these characteristics and minimum conditions for inspection should be laid down in the light of the present state of scientific and technical knowledge;  Whereas 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 Member States shall provide that official inspections carried out for the acceptance of vegetable varieties shall cover at least the characteristics listed in Annex I.  They shall ensure that the minimum conditions listed in Annex II are fulfilled at the time of the inspections.    Article 2 Member States shall bring into force not later than 1 July 1972 the laws, regulations or administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.    Article 3 This Directive is addressed to the Member States.     Done at Brussels, 14 April 1972.  For the Commission  The President  S.L. MANSHOLT  1 OJ No L 225, 12.10.1970, p. 7. 2 OJ No L 87, 17.4.1971, p. 24.     ANNEX I 1. ONION Allium cepa L.     1. Leaves:      1.1 height           1.2 colour           1.3 glaucescence : presence or absence                  2. Bulb:      2.1 colour of outer skin           2.2 colour of the flesh           2.3 ring formation of the flesh           2.4 shape           2.5 dry matter content                  3. Classification of early maturity         2. LEEK Allium porrum L.     1. Leaves:      1.1 habit           1.2 shape of the lamina           1.3 surface appearance           1.4 colour           1.5 anthocyanin : presence or absence (to be measured after a cold spell)                  2. Stem:      2.1 length           2.2 thickness           2.3 shape                  3. Seed (ripe and dry) : size       4. Speed of growth       5. Resistance to cold         3. CHERVIL Anthriscus cerefolium (L.) Hoffm.    1. Habit of the plant   2. Leaf:    2.1 colour       2.2 surface       2.3 shape of the folioles       2.4 indentation of the folioles   3. Flower : length of the scape         4. CELERY Apium graveolens I     A. Ribbed celery      1. Plant:        1.1 habit               1.2 suckers : presence or absence                          2. Leaves:        2.1 colour               2.2 variegation : presence or absence                          3. Petiole:        3.1 structure : solid or hollow               3.2 colour               3.3 anthocyanin : presence or absence               3.4 length               3.5 width               3.6 shape of cross-section                          4. Propensity to whiten : natural or artificial                  B. Celeriac      1. Leaves (at the beginning of tuber development):        1.1 habit               1.2 height               1.3 number               1.4 size of the folioles               1.5 anthocyanin on the petiole : presence or absence                          2. Tuber:        2.1 size               2.2 shape               2.3 size of protrusions               2.4 type of insertion of roots               2.5 number of roots               2.6 thickness of roots               2.7 appearance of epidermis                          3. Colour on cooking    5. ASPARAGUS Asparagus officinalis L.     1. Turion:      1.1 intensity of the anthocyanic colouring of the tip           1.2 diameter                  2. Sexual distribution : bisexual or male variety       3. Classification of early maturity         6. SPINACH BEET, CHARD Beta vulgaris L. var. cycla (L.) Ulrich     1. Plant:      1.1 shoots : presence or absence           1.2 habit of the leaves                  2. Leaf (at the adult plant stage):      2.1 length, including petiole           2.2 shape           2.3 blistering           2.4 colour           2.5 width of the main leaf-vein system           2.6 cross-section of the petiole                  3. Monogerm         7. RED BEET or BEETROOT Beta vulgaris L. var esculenta L.     1. Leaves:      1.1 Leaf/root ratio           1.2 intensity of anthocyanic colouring                  2. Root:      2.1 shape           2.2 shape of the base           2.3 appearance of cork on the skin           2.4 external colour           2.5 colour of the flesh                  3. Monogerm       4. Classification of early maturity    8. CURLY KALE Brassica oleracea L. var. acephala D.C. subvar. Laciniata L.     1. Height of stalk       2. Leaf:      2.1 shape           2.2 colour           2.3 degree of curl                    9. CAULIFLOWER Brassica oleracea L. convar. Botrytis (L) Alef. var. botrytis     1. Young plant : anthocyanin : presence or absence       2. Mature plant : size       3. Stalk : length       4. External leaves of mature plant:      4.1 habit           4.2 shape of the lamina           4.3 colour           4.4 curling of the ends           4.5 blistering           4.6 size of the main leaf-vein system                  5. Flower:      5.1 size           5.2 shape           5.3 relief           5.4 firmness           5.5 pilosity : presence or absence           5.6 anthocyanin : presence or absence                  6. Classification of early maturity         10. SPROUTING BROCCOLI or CALABRESE Brassica oleracea L. convar. botrytis L. Alef. var. italica Plenck    1. Stalk:    1.1 length       1.2 ramifications : presence or absence   2. Leaf:      2.1 undulation of edges of the lamina           2.2 anthocyanin : presence or absence   3. Inflorescence (before blooming of the first flower):        3.1 size               3.2 shape               3.3 firmness               3.4 colour               3.5 bracts : apparent or non-apparent               3.6 likelihood of second flowering                            11. BRUSSELS SPROUTS Brassica oleracea L. var. bullata subvar. gemmifera D C.     1. Stalk : length (at the mature plant stage)       2. Leaf : colour       3. Sprout:      3.1 size           3.2 shape                  4. Classification of early maturity         12. SAVOY CABBAGE Brassica oleracea L. var. bullata D C. et var. sabauda L.   13. CABBAGE Brassica oleracea L. var. capitata L.f. alba D C.   14. RED CABBAGE Brassica oleracea L. var. capitata L.f. rubra (I.) Thell     1. Plant      1.1 size           1.2 stalk : length                  2. External leaf:      2.1 colour           2.2 curling : presence or absence           2.3 presence of wax    3. Head:        3.1 size               3.2 shape   4. Classification of early maturity             15. KOHLRABI Brassica oleracea L. var. gongylodes L.     1. Plant : size       2. Leaf : colour       3. Tuber:      3.1 shape           3.2 colour                  4. Classification of occurrence of fibrousness       5. Classification of early maturity         16. SPRING TURNIP - AUTUMN TURNIP Brassica rapa L. var. rapa (L.) Thell     1. Leaves (to be noted just before harvesting and from mature plants):      1.1 type of leaf : whole or not           1.2 leaf/root ratio                  2. Root:      2.1 shape           2.2 colour of top           2.3 colour of the flesh                    17. CHILI, PEPPER, CAPSICUM Capsicum annuum L.     1. Seedling:      1.1 anthocyanin on the hypocotyl axis : presence or absence           1.2 intensity of green colouring on the hypocotyl axis                  2. Plant : length between nodes       3. Fruit:      3.1 habit 3.2 size   3.3 shape (excluding the first fruit)        3.3.1 shape of longitudinal cross-section               3.3.2 shape of the peduncle               3.3.3 shape of the apex                          3.4 colour        3.4.1 colour (before ripening)               3.4.2 colour (when ripe)                          3.5 thickness of the flesh           3.6 appearance of the surface of the fruit           3.7 capsaicin : presence or absence                  4. Classification of early maturity         18. ENDIVE Cichorium endivia L.     1. Habit of the plant       2. Leaves:      2.1 appearance of the heart           2.2 shape of young leaves of the heart (Scarole)           2.3 shape of the mature plant           2.4 colour of the leaf           2.5 shine of the leaf           2.6 appearance of the surface of the lamina (Scarole)           2.7 appearance of the edge of the lamina           2.8 anthocyanin on the principal leaf veins : presence or absence (Frisée)                  3. Classification of early maturity       4. Resistance to bolting         19. CHICORY Cichorium intybus L. var. foliosum Bisch    A. Witloof chicory    1. Leaves: tendency to early drying (to be noted in the Autumn of the 1st year)       2. Head : shape       3. Classification of early maturity on forcing       4. Rate of growth of the heart   B. Large-leaved chicory (Italian chicory)      1. Leaf (vegetative phase):        1.1 shape               1.2 anthocyanin : presence or absence                          2. Heart:        2.1 shape               2.2 shoots : presence or absence               2.3 anthocyanin : presence or absence               2.4 intensity of green colouring               2.5 blistering of the leaf                                   20. WATER MELON Citrullus vulgaris L.     1. Stalks:      1.1 anthocyanin : presence or absence           1.2 pilosity : presence or absence                  2. Leaf (at the beginning of flowering):      2.1 depth of denticulation           2.2 pilosity : presence or absence                  3. Flower (at the time of formation of the first fruits):      3.1 shape of the corolla           3.2 pilosity of the calyx : presence or absence                  4. Sex       5. Fruit (at the stage preceding ripeness)      5.1 size           5.2 shape           5.3 ribs : presence or absence           5.4 basic colour of the rind (epicarp)           5.5 colour of marbling of the rind (epicarp)           5.6 colour of the flesh (endocarp)           5.7 flesh cavity : presence or absence           5.8 texture of the flesh           5.9 seeds : presence or absence                  6. Seed : (ripe and dry)      6.1 size           6.2 shape           6.3 colour : unicoloured or multicoloured                  7. Ploidy level    21. MELON Cucumis melo L.     1. Seedling:      1.1 length of the hypocotyl axis           1.2 size of the cotyledons                  2. Sex       3. Fruit:      3.1 size           3.2 shape           3.3 loosening of the penduncle           3.4 ribs           3.5 broderic           3.6 colour of the rind (before ripening)           3.7 colour of the rind (when ripe)           3.8 marbling and specks           3.9 colour of the flesh                  4. Seed : (ripe and dry)      4.1 size           4.2 colour                  5. Classification of the sugar content of the fruit (when ripe)       6. Classification of early maturity         22. CUCUMBER - GHERKIN Cucumis sativus L.     1. Seedling : bitterness : presence or absence       2. Inflorescence : number of female flowers at each female level       3. Sex       4. Fruit:      4.1 length           4.2 colour (before ripening and when ripe)           4.3 size and colour of thorns           4.4 size and colour of hairs           4.5 number and size of warts           4.6 grooves           4.7 broderic of the ripe fruit  4.8 neck : presence or absence           4.9 parthenocarpic development           4.10 bitterness : presence or absence                  5. Classification of early maturity         23. MARROW Cucurbita pepo L.     1. Type of growth of the plant       2. Stalks:      2.1 length between the nodes           2.2 cross-section                  3. Leaf (at the beginning of flowering):      3.1 shape           3.2 depth of denticulations           3.3 stains : presence or absence           3.4 tendrils : presence or absence                  4. Flowers:      4.1 length of the penduncle of male flowers           4.2 corolla of female flowers : persistence or non-persistence                  5. Sexual distribution       6. Fruit:      6.1 shape (at the harvesting stage)           6.2 ribs : presence or absence (at the harvesting stage)           6.3 basic colour of the rind (at the harvesting stage)           6.4 colour of the marbling of the rind (at the harvesting stage)           6.5 colour of the rind (when fully ripe)           6.6 marbling : presence or absence (when fully ripe)                  7. Seed (ripe and dry) : size       8. Classification of early maturity         24. CARROT Daucus carota L. ssp. sativus (Hoffm.) Hayek     1. Leaves : height       2. Root:      2.1 length           2.2 shape           2.3 external colour    3. Seed (ripe and dry)-pilosity : presence or absence  4. Classification of early maturity             25. FENNEL Foeniculum vulgare P. Mill.     1. Habit of the plant       2. Leaf : dimensions of laciniae       3. Grumolo:      3.1 shape           3.2 imbrications of sheaths           3.3 fibrousness of sheaths           3.4 shoots : presence or absence                    26. LETTUCE Lactuca sativa L.     1. Seedling:      1.1 hypocotyl axis : anthocyanin : presence or absence           1.2 cotyledons : anthocyanin : presence or absence (before opening out)                  2. Leaf : (to be noted from the 3rd and 4th leaf of the young plant)      2.1 habit           2.2 overall shape           2.3 shape of the base           2.4 shape of the tip           2.5 undulation of the edge of the leaf           2.6 contour of the upper half           2.7 contour of the lower half           2.8 intensity and shade of colouring           2.9 anthocyanin : presence or absence                  3. Plant : (at the harvesting stage)      3.1 type of heart           3.2 profile of the heart           3.3 texture of the leaves           3.4 blistering of the external leaves           3.5 intensity and shade of colour of the external leaves           3.6 anthocyanin of the external leaves : presence or absence                  4. Seed (ripe and dry) : colour       5. Classification of early hearting-up       6. Classification of speed of heading in long days    27. PARSLEY Petroselinum hortense Hoffm.     1. Leaves:      1.1 height           1.2 shape           1.3 colour                  2. Type of root         28. RUNNER BEAN Phaseolus coccineus L.     1. Type of growth       2. Flower : colour       3. Pod:      3.1 length           3.2 fibres : presence or absence                  4. Seed (ripe and dry) : colour         29. FRENCH BEAN Phaseolus vulgaris L.     1. Seedling : colour of the hypocotyl axis       2. Type of growth : dwarf or climbing       3. Leaf : colour of the petiolule, in particular at the node       4. Inflorescence:      4.1 colour of the flower (unicoloured or bicoloured)           4.2 size of the floral bracts                  5. Pod:      5.1 length           5.2 transversal cut           5.3 surface appearance           5.4 fibres : presence or absence           5.5 parchment : presence or absence           5.6 constriction : between the seeds and at the level of the seeds           5.7 basic colour and superimposed colour           5.8 length and shape of the style           5.9 number of ovules   6. Seed (ripe and dry):        6.1 size               6.2 shape of longitudinal cross-section               6.3 shape of transversal cross-section               6.4 colour (excluding hilum ring)               6.5 colour of the hilum ring               6.6 colour of the halo               6.7 nervation  7. Classification of early maturity  8. Resistance to Colletotrichum Lindemuthianum                 30. PEA Pisum sativum L. (excl. P. arvense L.)     1. Plant      1.1 type of growth (dwarf or climbing)           1.2 number of the 1st floral node (excluding the cotyledon node)                 2. Leaf:      2.1 colour           2.2 maculation of the stipules : presence or absence                  3. Inflorescence:      3.1 number of flowers by inflorescence           3.2 shape of the base of the vexillum : in V shape or not                  4. Pod:      4.1 length (in the dry state)           4.2 shape of the free end           4.3 dorsal profile (at the 2nd floral node)           4.4 colour of the green seed           4.5 parchment : presence of absence           4.6 number of ovules                  5. Seed (ripe and dry):      5.1 size           5.2 shape (including appearance)           5.3 colour of the tegument           5.4 colour of the cotyledons           5.5 shape of the grains of starch (simple or compound)    31. RADISH Raphanus sativus L.     A. Raphanus sativus L. var. niger Pers.      1. Leaf : (observations from the 4th to the 7th leaf)        1.1 length               1.2 general shape               1.3 denticulation               1.4 colour of the petiole               1.5 size of the terminal foliole               1.6 colour of the terminal foliole                          2. Root:        2.1 size               2.2 shape               2.3 shape of shoulders               2.4 colour of the shoulders               2.5 shape of the end               2.6 appearance of the epidermis               2.7 colour of the epidermis                          3. Classification of early maturity                  B. Raphanus sativus L. var. radicula Pers.      1. Leaf : (observations from the 3rd leaf)        1.1 length               1.2 general shape               1.3 denticulation               1.4 colour                          2. Root:        2.1 shape               2.2 colour of the epidermis                          3. Classification of early maturity                    32. SCORZONERA OR BLACK SALSIFY Scorzonera hispanica L.    1. Root:    1.1 length       1.2 shape       1.3 appearance of epidermis       1.4 colour of epidermis   33. TOMATO Solanum lycopersicum L. (Lycopersicum esculentum Mill.)     1. Seedling : anthocyanin on the hypocotyl axis : presence or absence       2. Type of growth : determinate or indeterminate       3. Shape of the leaf : normal or whole folioles       4. Fruit:      4.1 size1           4.2 shape1           4.3 colour (before ripening)           4.4 colour (when ripe)           4.5 number of loculi1                  5. Classification of early maturity:      5.1 period between germination and the blooming of the 3rd flower of the 1st bunch (field trial)           5.2 period between flowering and ripeness1                  6. Resistance:      6.1 to Verticillium alboatrum           6.2 to Fusarium oxysporum                    34. AUBERGINE or EGG PLANT Solanum melongena L.     1. Seedling:      1.1 anthocyanin on the hypocotyl axis : presence or absence           1.2 habit of the cotyledons           1.3 shape of the cotyledons                  2. Plant:      2.1 length between the nodes           2.2 shape of the mature leaf           2.3 pilosity of the end of the stems           2.4 anthocyanin on the ends of the stems : presence or absence           2.5 spinosity (to be noted from the calyx)                  3. Fruit:      3.1 size           3.2 shape           3.3 colour  1 3rd fruit of the 2nd and 3rd bunches, ripeness assessed at the beginning of colouring.            3.4 shine           3.5 distribution of pigments           3.6 pigments under the calyx : presence or absence           3.7 anthocyanin : presence or absence           3.8 nature of the anthocyanin           3.9 colour of the flesh                  4. Classification of early maturity : period between germination and flowering         35. SPINACH Spinacia oleracea L.     1. Plant : rate of growth       2. Leaf : (at the stage of maximum development of the first four leaves)      2.1 habit of the petiole           2.2 length of the petiole           2.3 colour                  3. Leaves : (to be noted from the 7th leaf when the plants reach maximum development)      3.1 habit of the petiole           3.2 length of the petiole           3.3 colour           3.4 shape of the lamina           3.5 surface of the lamina                  4. Seed (ripe and dry) : shape       5. Classification of bolting       6. Sexual distribution       7. Resistance to Peronospora spinacial         36. CORN-SALAD or LAMB'S LETTUCE Valerianella locusta (L.) Betcke (v. olitoria Polt.)     1. Size of plant       2. Leaf (at the harvesting stage):      2.1 habit           2.2 shape           2.3 colour           2.4 surface : smooth or veined           2.5 pilosity : presence or absence           2.6 shape of the edge of the leaf (to be noted from the tip)           2.7 indentation : presence or absence   3. Seed (ripe and dry):        3.1 size               3.2 shape  4. Classification of early maturity                 37. BROAD BEAN Vicia faba major L.     1. Stalk : length       2. Stipule : maculated or not       3. Flower : colour       4. Pod:      4.1 habit           4.2 length           4.3 number of ovules                  5. Seed : (ripe and dry)      5.1 size           5.2 general colour           5.3 tannin : presence or absence           5.4 colour of the hilum                    38. POPCORN Zea mays convar. Microsperma Koern.   39. SWEET CORN Zea mays convar. Saccharata Koern.     1. Stalk:      1.1 anthocyanin on the nodes : presence or absence           1.2 level of insertion of the upper ear on the principal stem                  2. Ear:      2.1 colour of the stigmas (two to three days after coming out)           2.2 length of the peduncle           2.3 length of the spathes           2.4 colour of the stalk (at the stage of full ripeness)                  3. Seed:      3.1 type of seed harvested           3.2 shape           3.3 colour of the apex and of the sides                  4. Period between germination and:      4.1 the male flowering           4.2 the female flowering                      ANNEX II A. MINIMUM GENERAL CONDITIONS >PIC FILE= "T0038259">   >PIC FILE= "T0038260">    B. SPECIAL REMARKS     1. The person making the application shall make available to the competent authorities the quantities of seed that the latter consider necessary in order to carry out the trials and subsequent inspections.       2. The seed must satisfy the quality conditions for seed laid down in Annex II of the Council Directive1 of 29 September 1970 on the marketing of vegetable seed.       3. In the case of perennial plants the trials must be continued until all the characteristics have been observed and noted at least once.       4. If it is not certain whether the method of inspection used in one Member State is also applied in the other Member States this method must be indicated.       5. If the number of trial grounds per year is not adhered to, the number of plots per year should be increased accordingly.       6. The minimum conditions laid down in part A may be reduced for checking genealogical factors.  1 OJ No L 225, 12.10.1970, p. 7.


Avis juridique important

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31975L0319

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

Official Journal L 147 , 09/06/1975 P. 0013 - 0022 Finnish special edition: Chapter 13 Volume 4 P. 0098  Greek special edition: Chapter 13 Volume 3 P. 0066  Swedish special edition: Chapter 13 Volume 4 P. 0098  Spanish special edition: Chapter 13 Volume 4 P. 0092  Portuguese special edition Chapter 13 Volume 4 P. 0092

SECOND COUNCIL DIRECTIVE  of 20 May 1975  on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products  (75/319/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 approximation begun by Council Directive 65/65/EEC (3) of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products should be continued and the implementation of the principles laid down in that Directive should be ensured;  Whereas in order to reduce the disparities which remain, rules should be laid down on the control of proprietary medicinal products and the duties incumbent upon the Member States' competent authorities should be specified with a view to ensuring compliance with legal requirements;  Whereas, in order to progress towards free movement of proprietary medicinal products, the issue of authorizations to place one and the same proprietary medicinal product on the market in two or more Member States should be facilitated;  Whereas, for this purpose, a Committee for Proprietary Medicinal Products should be set up, consisting of representatives of the Member States and of the Commission, responsible for giving an opinion as to whether a particular proprietary medicinal product complies with the requirements set out in Directive 65/65/EEC;  Whereas this Directive represents merely one step towards achievement of the objective of the free movement of proprietary medicinal products ; whereas, therefore, further measures with a view to abolishing any remaining barriers to the free movement of proprietary medicinal products will be necessary in the light of experience gained, particularly in the abovementioned Committee;  Whereas in order to facilitate the movement of proprietary medicinal products and to prevent the controls carried out in one Member State from being repeated in another, minimum requirements should be laid down for manufacture and imports coming from third countries and for the grant of the authorization relating thereto;  Whereas it should be ensured that, in the Member States, the supervision and control of the manufacture of proprietary medicinal products is carried out by a person who fulfils minimum conditions of qualification;  Whereas, moreover, the provisions of this Directive and of that of Directive 65/65/EEC which relate to proprietary medicinal products, although appropriate, are inadequate for vaccines, toxins and serums, proprietary medicinal products based on human blood or blood constituents, proprietary medicinal products based on radio-active isotopes and homeopathic proprietary medicinal products ; whereas the application thereof should consequently not be imposed at the present time in respect of such proprietary medicinal products;  Whereas certain rules in this Directive entail amendments to various provisions of Directive 65/65/EEC,  HAS ADOPTED THIS DIRECTIVE:    CHAPTER I Application for authorization to place proprietary medicinal products on the market  Article 1 Member States shall take all appropriate measures to ensure that the documents and particulars listed  (1)OJ No 96, 2.6.1965, p. 1677/65. (2)OJ No 107, 19.6.1965, p. 1825/65. (3)OJ No 22, 9.2.1965, p. 369/65.   in points 7 and 8 of Article 4, second paragraph, of Directive 65/65/EEC are drawn up by experts with the necessary technical or professional qualifications before they are submitted to the competent authorities. These documents and particulars shall be signed by the experts.   Article 2 The duties of the experts according to their respective qualifications shall be:    (a) to perform tasks falling within their respective disciplines (analysis, pharmacology and similar experimental sciences, clinical trials) and to describe objectively the results obtained (qualitatively and quantitatively);       (b) to describe their observations in accordance with Council Directive 75/318/EEC (1) of 20 May 1975, on the approximation of the laws of the Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products, and to state, in particular:      - in the case of the analyst, whether the product is consistent with the declared composition, giving any substantiation of the control methods employed by the manufacturer;           - in the case of the pharmacologist or the specialist with similar experimental competence, the toxicity of the product and the pharmacological properties observed;           - in the case of the clinician, whether he has been able to ascertain effects on persons treated with the product which correspond to the particulars given by the applicant in accordance with Article 4 of Directive 65/65/EEC, whether the patient tolerates the product well, the posology the clinician advises and any contra-indications and side-effects;                  (c) where applicable, to state the grounds for using the published references mentioned in point 8 (a) and (b) of Article 4, second paragraph, of Directive 65/65/EEC under the conditions set out in Directive 75/318/EEC.         Detailed reports by the experts shall form part of the particulars accompanying the application which the applicant submits to the competent authorities.   Article 3 In the event of Article 2 of this Directive not being complied with, Article 5, second paragraph, of Directive 65/65/EEC shall apply.  CHAPTER II Examination of the application for authorization to place proprietary medical products on the market  Article 4 In order to examine the application submitted in accordance with Article 4 of Directive 65/65/EEC, the competent authorities of the Member States:    (a) must verify whether the particulars submitted in support of the application comply with the said Article 4 and examine whether the conditions for issuing an authorization to place proprietary medicinal products on the market (marketing authorization) are complied with;       (b) may submit the proprietary medicinal product for testing by a State laboratory or by a laboratory designated for that purpose in order to ensure that the control methods employed by the manufacturer and described in the particulars accompanying the application in accordance with point 7 of Article 4, second paragraph, of Directive 65/65/EEC are satisfactory;       (c) may, where appropriate, require the applicant to supplement the particulars accompanying the application in respect of the items listed in the second paragraph of Article 4 of Directive 65/65/EEC. Where the competent authorities avail themselves of this option, the time limits laid down in Article 7 of the said Directive shall be suspended until such time as the supplementary information required has been provided. Likewise, these time limits shall be suspended for the time allowed the applicant, where appropriate, for giving oral or written explanation.          Article 5 Member States shall take all appropriate measures to ensure that:    (a) the competent authorities verify that manufacturers and importers of products coming from third countries are able to carry out manufacture in compliance with the particulars supplied pursuant to point 4 of Article 4, second paragraph, of Directive 65/65/EEC and/or to carry out controls according to the methods described in the particulars accompanying the application in accordance with point 7 of Article 4, second paragraph, of that Directive;  (1)See page 1 of this Official Journal.        (b) the competent authorities may allow manufacturers and importers of products coming from third countries, in exceptional and justifiable cases, to have certain stages of manufacture and/or certain of the controls referred to in (a) carried out by third parties ; in such cases, the verifications by the competent authorities shall also be made in the establishment designated.          Article 6 Where a leaflet is enclosed with the packaging of a proprietary medicinal product Member States shall take all appropriate measures to ensure that it applies to the product in question only.  All the information given in the leaflet must be in accordance with the particulars and documents supplied pursuant to Article 4 of Directive 65/65/EEC and must be approved by the competent authorities.  The leaflet must include at least the following information:    (a) name and domicile or corporate name and domicile or registered place of business of the person responsible for marketing the product and, where applicable, of the manufacturer;       (b) name and qualitative and quantitative particulars of the product in terms of its active ingredients.  The international non-proprietary names recommended by the World Health Organization should be used where such names exist;       (c) in the absence of a decision to the contrary by the competent authorities:      - therapeutic indications,           - contra-indications, side effects and special precautions for use.             Information and decisions under the first and second indents shall take into account the results of the clinical trials and pharmacological tests provided for in point 8 of Article 4, second paragraph, of Directive 65/65/EEC and in the case of the information referred to under the second indent, of experience acquired in use after marketing;       (d) directions for use of the product (method of administration, duration of treatment if this should be limited, normal dosage);       (e) special storage precautions, where applicable.         Other information shall be clearly separate from that referred to above.  Member State may require that a leaflet be included with the packaging.   Article 7 Notwithstanding the provisions of Chapter IV and of Article 21 of Directive 65/65/EEC, Member States may require that the proprietary medicinal product shall be labelled so as to indicate on the container and/or outer packaging and/or on the package leaflet other requirements essential to safety or for the protection of public health, including any particular precautions to be taken in using the product and any other warnings based on the results of the clinical trials and pharmacological tests mentioned in point 8 of Article 4, second paragraph, of Directive 65/65/EEC, or resulting from experience in the course of use of the proprietary medicinal product after marketing.  CHAPTER III Committee for Proprietary Medicinal Products   Article 8 1. In order to facilitate the adoption of a common position by the Member States regarding marketing authorizations, a Committee for Proprietary Medicinal Products, hereinafter referred to as "the Committee", is hereby set up. The Committee shall consist of representatives of the Member States and of the Commission.  2. The responsibility of the Committee shall be to examine, in accordance with Articles 9 to 14, the questions referred to it by a Member State concerning the application of Articles 5, 11 or 20 of Directive 65/65/EEC.  3. The Committee shall draw up its own Rules of Procedure.   Article 9 1. The Member State which has issued a marketing authorization for a proprietary medicinal product shall forward to the Committee a dossier containing a copy of the authorization together with the particulars and documents specified in Article 4,   second paragraph, of Directive 65/65/EEC, if the person responsible for marketing has requested the forwarding to at least five other Member States.  2. The Committee shall forthwith forward the dossier to the competent authorities of the Member States so specified.  3. Such forwarding shall be deemed to be equivalent to submitting an application for marketing authorization, within the meaning of Article 4 of Directive 65/65/EEC, to the said authorities.   Article 10 1. If, within a period of 120 days after the date of the forwarding referred to in Article 9 (2), no objection is notified to the Committee by the competent authorities of the Member States specified, the Committee shall formally record the fact and forthwith inform the Member States concerned.  2. Where a Member State considers that it is unable to authorize the marketing of the proprietary medicinal product, it shall forward its reasoned objection, within the said period of 120 days, on the basis of Article 5 of Directive 65/65/EEC.   Article 11 1. In the cases referred to in Article 10 (2), the Committee shall consider the matter and give a reasoned opinion within not more than 60 days from the expiry of the time limit laid down in Article 10.  2. The opinion of the Committee shall deal with the compliance of the proprietary medicinal product with the conditions set out in Article 5 of Directive 65/65/EEC.  The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of a divergence, of the opinions of its members.  3. The Member States concerned shall reach a decision on the application for marketing authorization not more than 30 days after the date on which the information provided for in Article 10 (1) or paragraph 2 of this Article is given. They shall forthwith inform the Committee of their decision.   Article 12 1. If several applications submitted in accordance with Article 4 of Directive 65/65/EEC have been made for marketing authorization for a particular proprietary medicinal product, and one or more Member States have granted an authorization while one or more of the other Member States have refused it, one of the Member States concerned may bring the matter before the Committee.  The same shall apply where one or more Member States have suspended or revoked the marketing authorization while one or more other Member States have not done so.  2. The Committee shall consider the matter and give a reasoned opinion within 120 days at the most.  3. The opinion of the Committee shall only deal with the grounds on which authorization was refused, suspended or revoked.  The Committee shall forthwith inform the Member States concerned of its opinion or, in the event of a divergence, of the opinions of its members.  4. The Member States concerned shall give notice within 30 days of the action they intend to take following the Committee's opinion.   Article 13 The Committee may set a time limit for a fresh examination on the basis of particulars relating to the conditions laid down in Articles 5, 11 or 20 of Directive 65/65/EEC obtained in the meantime by the Member States, in particular by those which have authorized the proprietary medicinal product.   Article 14 The competent authorities of Member States may, in specific cases where the interests of the Community are involved, refer the matter to the Committee before reaching a decision on an application for a marketing authorization, its suspension or revocation.   Article 15 1. The Commission shall report to the Council annually on the operation of the procedure laid down in this Chapter and its effects on the development of intra-Community trade. It shall report for the first time two years after the entry into force of this Directive.  2. In the light of experience the Commission shall, not later than four years after the entry into force of this Directive, submit to the Council a proposal containing appropriate measures leading towards the abolition of any remaining barriers to the free movement of proprietary medicinal products. The Council shall take a decision on the Commission proposal no later than one year after its submission.   CHAPTER IV Manufacture and imports coming from third countries   Article 16 1. Member States shall take all appropriate measures to ensure that the manufacture of the proprietary medicinal products is subject to the holding of an authorization.  2. The authorization referred to in paragraph 1 shall be required for both total and partial manufacture, and for the various processes of dividing up, packaging or presentation.  However, such authorization shall not be required for preparation, dividing up, changes in packaging or presentation where these processes are carried out, solely for retail supply, by pharmacists in dispensing pharmacies or by persons legally authorized in the Member States to carry out such processes.  3. Authorization referred to in paragraph 1 shall also be required for imports coming from third countries into a Member State ; this Chapter and Article 29 shall have corresponding application to such imports as they have to manufacture.   Article 17 In order to obtain the authorization referred to in Article 16, the applicant must meet at least the following requirements:    (a) specify the proprietary medicinal products and pharmaceutical forms which are to be manufactured or imported and also the place where they are to be manufactured and/or controlled;       (b) have at his disposal, for the manufacture or import of the above, suitable and sufficient premises, technical equipment and control facilities complying with the legal requirements which the Member State concerned lays down as regards both manufacture and control and the storage of products, in accordance with Article 5 (a).       (c) have at his disposal the services of at least one qualified person within the meaning of Article 21.         The applicant must provide particulars in support of the above in his application.   Article 18 1. The competent authority of the Member State shall issue the authorization referred to in Article 16 only after having made sure of the accuracy of the particulars supplied pursuant to Article 17, by means of an inquiry carried out by its agents.  2. In order to ensure that the requirements referred to in Article 17 are complied with, authorization may be made conditional on the carrying out of certain obligations imposed either when authorization is granted or at a later date.  3. The authorization shall apply only to the premises specified in the application and to the proprietary medicinal products and pharmaceutical forms specified in that same application.   Article 19 The holder of an authorization referred to in Article 16 shall at least be obliged:    (a) to have at his disposal the services of staff who comply with the legal requirements existing in the Member State concerned both as regards manufacture and controls;       (b) to dispose of the authorized proprietary medicinal products only in accordance with the legislation of the Member States 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 to Article 17 ; the competent authority shall in any event be immediately informed if the qualified person referred to in Article 21 is replaced unexpectedly;       (d) to allow the 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 21 to carry out his duties, for example by placing at his disposal all the necessary facilities.          Article 20 1. The Member States shall take all appropriate measures to ensure that the time taken for the procedure for granting the authorization referred to in Article 16 does not exceed 90 days from the day on which the competent authority receives the application.  2. If the holder of the authorization requests a change in any of the particulars referred to in Article 17 (a) and (b), the time taken for the procedure relating to this request shall not exceed 30 days. In exceptional cases this period of time may be extended to 90 days.  3. Member States may require from the applicant further information concerning the particulars supplied pursuant to Article 17 and concerning the qualified person referred to in Article 21 ; where the competent authority concerned exercises this right, application of the time limits referred to in paragraphs 1 and 2 shall be suspended until the additional data required have been supplied.    Article 21 1. Member States shall take all appropriate measures to ensure that the holder of the authorization referred to in Article 16 has permanently and continuously at his disposal the services of at least one qualified person, in accordance with the conditions laid down in Article 23, responsible in particular for carrying out the duties specified in Article 22.  2. If he personally fulfils the conditions laid down in Article 23, the holder of the authorization may himself assume the responsibility referred to in paragraph 1.   Article 22 1. Member States shall take all appropriate measures to ensure that the qualified person referred to in Article 21, without prejudice to his relationship with the holder of the authorization referred to in Article 16, is responsible, in the context of the procedures referred to in Article 25, for securing:    (a) in the case of proprietary medicinal products manufactured within the Member States concerned that each batch of proprietary medicinal products has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorization;       (b) in the case of proprietary medicinal products coming from third countries, that each production batch has undergone in the importing country a full qualitative analysis, a quantitative analysis of at least all the active constituents and all the other tests or checks necessary to ensure the quality of proprietary medicinal products in accordance with the requirements of the marketing authorization.         The batches of products which have undergone such controls in a Member State shall be exempt from the above controls if they are imported into another Member State, accompanied by the control reports signed by the qualified person.  A Member State may relieve the qualified person of responsibility for the controls prescribed under (b) for imported proprietary medicinal products which are to remain in that Member State, if appropriate arrangements have been made with the exporting country to ensure that those controls have been carried out in the exporting country. Where these products are imported in the packaging in which they are to be sold by retail, Member States may allow exceptions to the requirements laid down in Article 17.  2. In all cases and particularly where the proprietary medicinal products are released for sale the qualified person must certify in a register or equivalent document provided for that purpose that each production batch satisfies the provisions of this Article ; the said register or equivalent document must be kept up to date as operations are carried out and must remain at the disposal of the agents of the competent authority for the period specified in the provisions of the Member State concerned and in any event for at least five years.   Article 23 Member States shall ensure that the qualified person referred to in Article 21 fulfils the following minimum conditions of qualification:    (a) Possession of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognized as equivalent by the Member State concerned, extending over a period of at least four years of theoretical and practical study in one of the following scientific disciplines : pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology. However:      - the minimum duration of the university course may be three and a half years where the course is followed by a period of theoretical and practical training of a minimum duration of one year and including a training period of at least six months in a pharmacy open to the public, corroborated by an examination at university level;           - where two university courses or two courses recognized by the State as equivalent co-exist in a Member State and where one of these extends over four years and the other over three years, the three-year course leading to a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course or its recognized equivalent shall be considered to fulfil the condition of duration referred to in (a) in so far as the diplomas, certificates or other evidence of formal qualifications awarded on completion of both courses are recognized as equivalent by the State in question.             The course shall include theoretical and practical study bearing upon at least the following basic subjects:  Applied physics  General and inorganic chemistry  Organic chemistry  Analytical chemistry  Pharmaceutical chemistry, including analysis of medicinal products  General and applied biochemistry (medical)  Physiology  Microbiology  Pharmacology  Pharmaceutical technology  Toxicology  Pharmacognosy (medical aspects) (study of the composition and effects of the active principles of natural substances of plant and animal origin).  Studies in these subjects should be so balanced as to enable the person concerned to fulfil the obligations specified in Article 22.  In so far as certain diplomas, certificates or other evidence of formal qualifications mentioned in (a) do not fulfil the criteria laid down above, the competent authority of the Member State shall ensure that the person concerned provides evidence of adequate knowledge of the subjects involved.       (b) Practical experience for at least two years, in one or more undertakings which are authorized to manufacture proprietary medicinal products, in the activities of qualitative analysis of medicinal products, of quantitative analysis of active substances and of the testing and checking necessary to ensure the quality of proprietary medicinal products.         The duration of practical experience may be reduced by one year where a university course lasts for at least five years and by a year and a half where the course lasts for at least six years.   Article 24 1. A person engaging in the activities of the person referred to in Article 21 in a Member State at the time when this Directive is brought into force in that State but without complying with the provisions of Article 23 shall be eligible to continue to engage in those activities in the State concerned.  2. The holder of a diploma, certificate or other evidence of formal qualifications awarded on completion of a university course - or a course recognized as equivalent by the Member State concerned - in a scientific discipline allowing him to engage in the activities of the person referred to in Article 21 in accordance with the laws of that State may - if he began his course prior to the notification of this Directive - be considered as qualified to carry out in that State the duties of the person referred to in Article 21 provided that he has previously engaged in the following activities for at least two years before the end of the tenth year following notification of this Directive in one or more undertakings authorized pursuant to Article 16 : production supervision and/or qualitative analysis, quantitative analysis of active substances, and the necessary testing and checking under the direct authority of the person referred to in Article 21 to ensure the quality of the proprietary medicinal products.  If the person concerned has acquired the practical experience referred to in the first subparagraph more than 10 years prior to the notification of this Directive, a further one year's practical experience in accordance with the conditions referred to in the first subparagraph will be required to be completed immediately before he engages in such activities.  3. A person who, at the time when this Directive is brought into force, is engaged in direct collaboration with a person referred to in Article 21 in production supervision activities and/or in qualitative and quantitative analysis of active substances and the testing and checking necessary to ensure the quality of proprietary medicinal products may, for a period of five years after this Directive has been brought into force, be considered as qualified to take up in that State the duties of the person referred to in Article 21 provided that that Member State ensures that the person shows evidence of adequate theoretical and practical knowledge and has engaged in the activities mentioned for at least five years.   Article 25 Member States shall ensure that the duties of qualified persons referred to in Article 21 are fulfilled, either by means of appropriate administrative measures or by making such persons subject to a professional code of conduct.  Member States may provide for the temporary suspension of such a person upon the commencement of administrative or disciplinary procedures against him for failure to fulfil his obligations.  CHAPTER V Supervision and sanctions   Article 26 The competent authority of the Member State concerned shall ensure by means of inspections that the legal requirements relating to proprietary medicinal products are complied with.  Such inspections shall be carried out by officials representing the competent authority who must be empowered to:    (a) inspect manufacturing or commercial establishments and any laboratories entrusted by the holder of the authorization referred to in Article   16 with the task of carrying out checks pursuant to Article 5 (b);       (b) take samples;       (c) examine any documents relating to the object of the inspection, subject to the provisions in force in the Member States at the time of notification of this Directive and which place restrictions on these powers with regard to the descriptions of the method of preparation.          Article 27 Member States shall take all appropriate measures to ensure that the person responsible for marketing a proprietary medicinal product and, where appropriate, the holder of the authorization referred to in Article 16, furnish proof of the controls carried out on the finished product and/or the ingredients and of the controls carried out at an intermediate stage of the manufacturing process, in accordance with the methods laid down for the purposes of the marketing authorization.   Article 28 1. Notwithstanding the measures provided for in Article 11 of Directive 65/65/EEC, Member States shall take all appropriate measures to ensure that the supply of the proprietary medicinal product shall be prohibited and the proprietary medicinal product withdrawn from the market if:    (a) the proprietary medicinal product proves to be harmful under normal conditions of use;       (b) it is lacking in therapeutic efficacy;       (c) its qualitative and quantitative composition is not as declared;       (d) the controls on the finished product and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the authorization referred to in Article 16 has not been fulfilled.         2. The competent authority may limit the prohibition to supply the product, or its withdrawal from the market, to those batches which are the subject of dispute.   Article 29 1. The competent authority of a Member State shall suspend or revoke the authorization referred to in Article 16 for a category of preparations or all preparations where any one of the requirements laid down in Article 17 is no longer met.  2. In addition to the measures specified in Article 28, the competent authority of a Member State may suspend manufacture or imports of proprietary medicinal products coming from third countries, or suspend or revoke the authorization referred to in Article 16 for a category of preparations or all preparations where Articles 18, 19, 22 and 27 are not complied with.  CHAPTER VI Miscellaneous provisions  Article 30 Member States shall take all appropriate measures to ensure that the competent authorities concerned communicate to each other such information as is appropriate to guarantee that the requirements for the authorizations referred to in Article 16 or marketing authorizations are fulfilled.   Article 31 All decisions taken pursuant to Articles 18, 28 and 29 and all negative decisions taken pursuant to Articles 5 (b) and 11 (3) shall state in detail the reasons on which they are based. Such decisions shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and of the time limit allowed for applying for such remedies.   Article 32 No decision concerning suspension of manufacture or of importation of proprietary medicinal products coming from third countries, prohibition of supply or withdrawal from the market of a proprietary medicinal product may be taken except on the ground set out in Articles 28 and 29.   Article 33 Each Member State shall take all the appropriate measures to ensure that decisions authorizing marketing, refusing or revoking a marketing authorization, cancelling a decision refusing or revoking a marketing authorization, prohibiting supply, or withdrawing a product from the market, together with the reasons on which such decisions are based, are brought to the attention of the Committee forthwith.    Article 34 This Directive shall apply only to proprietary medicinal products for human use.  Chapters II to V of Directive 65/65/EEC and this Directive shall not apply to proprietary medicinal products consisting of vaccines, toxins or serums, to proprietary medicinal products based on human blood or blood constituents or radioactive isotopes, or to homeopathic proprietary medicinal products. A list, for information purposes, of these vaccines, toxins and serums is given in the Annex.   Article 35 The following shall be substituted for point 7 of Article 4, second paragraph, of Directive 65/65/EEC:  "Description of the control methods employed by the manufacturer (qualitative and quantitative analysis of the constituents and of the finished product, special tests, e.g. sterility tests, tests for the presence of pyrogenic substances, the presence of heavy metals, stability tests, biological and toxicity tests, controls carried out at an intermediate stage of the manufacturing process)."   Article 36 The following shall be substituted for Article 11, second paragraph, of Directive 65/65/EEC:  "An authorization shall also be suspended or revoked where the particulars supporting the application as provided for in Article 4 are found to be incorrect, or when the controls referred to in Article 8 of this Directive or in Article 27 of the Second Council Directive 75/319/EEC (1) of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products have not been carried out."  The following footnote shall be added:   Article 37 The following shall be substituted for Article 24 of Directive 65/65/EEC:  "Within the time limits and under the conditions laid down in Article 39 (2) and (3) of second Directive 75/319/EEC, the rules laid down in this Directive shall be applied progressively to proprietary medicinal products covered by an authorization to place on the market by virtue of previous provisions".  CHAPTER VII Implementing provisions and transitional measures   Article 38 Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.  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 39 1. As regards the authorizations referred to in Article 16 issued before the expiry of the time limit laid down in Article 38, Member States may grant an additional period of one year to the undertakings concerned to enable them to comply with the provisions of Chapter IV.  2. Within 15 years of the notification referred to in Article 38, the other provisions of this Directive shall be applied progressively to proprietary medicinal products placed on the market by virtue of previous provisions. 3. Member States shall notify the Commission, within three years following the notification of this Directive, of the number of proprietary medicinal products covered by paragraph 2, and, each subsequent year, of the number of these products for which a marketing authorization referred to in Article 3 of Directive 65/65/EEC, has not yet been issued.   Article 40 This Directive is addressed to the Member States.     Done at Brussels, 20 May 1975.  For the Council  The President  R. RYAN  "(1) OJ No L 147, 9.6.75, p. 13."     ANNEX The expression "vaccines, toxins or serums" used in Article 34 shall cover in particular:  - agents used to produce active immunity  (such as cholera vaccine, BCG, polio vaccine, smallpox vaccine);  - agents used to diagnose the state of immunity  including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin;  - agents used to produce passive immunity  (such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin).


Avis juridique important

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31972L0430

Council Directive 72/430/EEC of 19 December 1972 amending Council Directive 72/166/EEC of 24 April 1972 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles and to the enforcement of the obligation to insure against such liability

Official Journal L 291 , 28/12/1972 P. 0162 - 0162 Finnish special edition: Chapter 6 Volume 1 P. 0114  Danish special edition: Series I Chapter 1972(31.12)L291 P. 0023  Swedish special edition: Chapter 6 Volume 1 P. 0114  English special edition: Series I Chapter 1972(28-30.12) P. 0077  Greek special edition: Chapter 06 Volume 1 P. 0143  Spanish special edition: Chapter 13 Volume 2 P. 0179  Portuguese special edition Chapter 13 Volume 2 P. 0179

COUNCIL DIRECTIVE  of 19 December 1972  amending Council Directive 72/166/EEC of 24 April 1972 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles and to the enforcement of the obligation to insure against such liability  (72/430/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty concerning the Accession of new Member States to the European Economic Community and to the European Atomic Community 1, signed at Brussels, on 22 January 1972, and in particular Article 153 of the Act annexed thereto;  Having regard to the proposal from the Commission;  Whereas following the enlargement of the Community the number of national bureaux taken into account in Council Directive 72/166 2 of 24 April 1972 on the approximation of the laws of the Member States relating to insurance against civil liability in respect of the use of motor vehicles, and to the enforcement of the obligation to insure against such liability is increased from six to nine, necessitating an adjustment to that Directive;  HAS ADOPTED THIS DIRECTIVE:    Article 1 Council Directive 72/166 shall be amended as follows : The following shall be substituted for the wording of Article 2 (2), first indent:  "after an agreement has been concluded between the nine national insurers' bureaux under the terms of which each national bureau guarantees the settlement, in accordance with the provisions of national law on compulsory insurance, of claims in respect of accidents occurring in its territory, caused by vehicles normally based in the territory of a another Member State, whether or not such vehicles are insured;".   Article 2 This Directive shall enter into force on the Accession of the new Member States to the European Communities.  This Directive is addressed to the Member States.     Done at Brussels, 19 December 1972.  For the Council  The President  T. WESTERTERP  1OJ No L 73, 27.3.1972, p. 1. 2OJ No L 103, 2.5.1972, p. 1.