CELEX: 51990PC0135(02)
Language: en
Date: 1990-04-26
Title: AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING DIRECTIVE 81/851/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO VETERINARY MEDICINAL PRODUCTS

N o C 131/16                                   Official Journal of the European Communities                                                 30. 5. 90
                              ORIGINAL TEXT                                                                         AMENDED TEXT
                                                                          ANNEX V
                                                              Points 1 to 4.3 unchanged
 4.4. National maximum residue limits.                                              4.4. Maximum residue limits.
                                                                 The rest is unchanged
               Proposal for a Council Directive amending Directive 81/851/EEC on the approximation of the
                                 laws of the Member States relating to veterinary medicinal products (')
                                                          COM(90) 135 final — SYN 189
                   (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990)
                                                                        (90/C 131/06)
               (') OJ No C 61, 10. 3. 1989, p. 11 (COM(88) 779 final — SYN 189).
                             ORIGINAL TEXT                                                                         AMENDED TEXT
                                                         Visas and recitals unchanged
                                 Article 1                                                                             Article 1
                                                             Paragraph 1 unchanged
               Paragraph           2 (Directive 8 1 / 8 5 1 / E E C , Article                 1 (5)) s u b p a r a g r a p h s    1 and 2
                                                                         unchanged
2.     Before the date of implementation of this Directive,                         2.       Before the date of implementation of this Directive,
Member States shall communicate to the Commission a                                 Member States shall communicate to the Commission a
list of the veterinary medicinal products which are                                 list of the veterinary medicinal products which are
available without veterinary prescription.                                          available without veterinary prescription.
                                                                                   When the Commission has received the communication
                                                                                   from the Member States, it shall examine whether to
                                                                                   propose appropriate measures for drawing up lists of
                                                                                   medicinal products which may be administered without
                                                                                   prescription within the Community.
                                                             Paragraph 3 unchanged
                  P a r a g r a p h 4 ( D i r e c t i v e 8 1 / 8 5 1 / E E C , A r t i c l e 4) s u b p a r a g r a p h 1 u n c h a n g e d
 ---pagebreak--- 30. 5. 90                            Official Journal of the European Communities                                  N o C 131/17
                       ORIGINAL TEXT                                                        AMENDED TEXT
2.    No veterinary medicinal product may be admin-                 2.     No veterinary medicinal product may be admin-
istered to animals unless the authorization referred to             istered to animals unless the authorization referred to
above has been issued, except for the tests of veterinary           above has been issued, except for the tests of veterinary
medicinal products referred to in point 10 of Article 5             medicinal products referred to in point 10 of Article 5
which have been notified to or approved by the                      which have been notified to or approved by the
competent national authorities in accordance with the               competent national authorities in accordance with the
national rules in force.                                            national rules in force.
                                                                    A written prescription shall be required for dispensing to
                                                                    the public the following veterinary medicinal products:
                                                                    (a) those subject to official restrictions on use for
                                                                         reasons of public or animal health;
                                                                    (b) those which, because of their residual effects in
                                                                         foodstuffs of animal origin, require monitoring in
                                                                         their administration in order to ascertain the relevant
                                                                         withdrawal period;
                                                                    (c) those which may present risks for animals or for
                                                                         public health or may cause disorders in the persons
                                                                         who administer them;
                                                                    (d) those intended for treatments or pathological
                                                                         processes which require a precise prior diagnosis or
                                                                         the use of which may cause effects which impede or
                                                                         interfere with subsequent diagnostic or therapeutic
                                                                         measures;
                                                                    (e) magistral formulae intended for animals;
                                                                    (f) those which contain narcotic or psychotropic drugs
                                                                         or any other substance subject to international
                                                                         restrictions.
                                             Paragraphs 3 and 4 unchanged
             Paragraph       5  (Directive    8 1 / 8 5 1 / E E C , Article     5)   subparagraphs      1 to    10
                                                           unchanged
11. a summary in accordance with Article 5a of the                  11. a summary in accordance with Article 5a of the
     product characteristics, one or more specimens or                   product characteristics, one or more specimens or
     mock-ups of the sales presentation of the veterinary                mock-ups of the sales presentation of the veterinary
     medicinal product together with a package insert                    medicinal product together with a package insert (six
     where one is to be enclosed.                                        words deleted).
                                          Subparagraphs 12 and 13 unchanged
                                                                    Subparagraph (new):
                                                                    14. Medicinal products containing new active ingredi-
                                                                         ents not included in Annexes I, II or III of the Regu-
                                                                         lation shall be accompanied by copies of the
                                                                         documents submitted to the Commission in
                                                                         accordance with Annex V of the Regulation.
 ---pagebreak--- N o C 131/18                             Official Journal of the European Communities                                              30. 5. 90
                      ORIGINAL TEXT                                                                   AMENDED TEXT
              Paragraph     6 (Article           5a of        Directive 8 1 / 8 5 1 / E E C )   subparagraphs           1 to 4
                                                                    unchanged
                                                       Subparagraph 5.0. unchanged
5.1. Therapeutic   indications,     specifying          the      target      5.1. Therapeutic indications specifying the target species,
     species.                                                                      diagnositic, preventative or other functions, in
                                                                                   accordance with the product characteristics and, in
                                                                                   general, any functional changes in the animal.
                               The rest of subparagraph 5 and subparagraph 6 is unchanged
                                                  P a r a g r a p h s 7 to 10 u n c h a n g e d
              Paragraph      11 ( D i r e c t i v e    8 1 / 8 5 1 / E E C , Article    16) s u b p a r a g r a p h s 1 and  2
                                                                    unchanged
3.    The Committee shall draw up its own rules of                           3.    The Committee shall draw up its own rules of
procedure.                                                                   procedure.
                                                                             Membership of the Committee shall be made public.
                                                                             When each appointment is published, the professional
                                                                             qualifications of each member shall be specified, and his
                                                                             links, if any, with industrial or commercial undertakings.
                                                                             The Committee members may not hold financial or other
                                                                             interests in the pharmaceutical industry which could
                                                                             affect their impartiality. All indirect interests which could
                                                                             relate to this industry shall be entered in a register held
                                                                             at the Commission which the public may consult.
              Paragraph      11 ( D i r e c t i v e   8 1 / 8 5 1 / E E C , Article     17) s u b p a r a g r a p h s 1 and  2
                                                                    unchanged
3.    The holder of the marketing authorization shall                        3.    The holder of the marketing authorization shall
notify the dates on which the dossiers were sent to the                      notify the Committee the dates on which the dossiers
Member States concerned. As soon as the Committee has                        were sent to the Member States concerned. The Member
noted that all the Member States concerned are in                            States shall immediately inform the Committee and the
possession of the dossier, it shall forthwith inform all the                 person responsible for placing the product on the market
Member States and the applicant of the date on which                         that they have received the dossier.
the last Member States concerned received the dossier.
The Member State(s) concerned shall either grant the                         As soon as the Committee has noted that all the Member
authorization valid for their markets within a period of                     States concerned are in possession of the dossier, it shall
120 days of the aforementioned date, taking into due                         forthwith inform all the Member States and the applicant
consideration the authorization issued within the                            of the date on which the last Member States concerned
meaning of paragraph 1, or put forward a reasoned                            received the dossier. The Member State(s) concerned
objection.                                                                   shall either grant the authorization valid for their
                                                                             markets within a period of 120 days of the aforemen-
                                                                             tioned date, taking into due consideration the authori-
                                                                             zation issued within the meaning of paragraph 1, or put
                                                                             forward a reasoned objection.
 ---pagebreak--- 30. 5. 90                                   Official Journal of the European Communities                                                N o C 131/19
                        ORIGINAL TEXT                                                                       AMENDED TEXT
              Paragraph       11 ( D i r e c t i v e 8 1 / 8 5 1 / E E C , A r t i c l e 18) s u b p a r a g r a p h 1 u n c h a n g e d
2.    Upon the expiry of this period the matter shall be                         2.     Upon the expiry of this period the matter shall be
referred to the Committee and the procedure referred to                          referred to the Committee and the procedure referred to
in Article 21 shall be applied.                                                  in Articles 21 and 22 shall be applied.
                                                            Subparagraph 3 unchanged
                          Article 19                                                                           Article 19
If several applications submitted in accordance with                             If several applications submitted in accordance with
Articles 5 and 5a have been made for a marketing                                 Article 5 and 5a have been made for a marketing
authorization for a particular veterinary medicinal                              authorization for a particular veterinary medicinal
product, and one or more Member States have granted                              product, and one or more Member States have granted
an authorization while one or more of the other Member                           an authorization while one or more of the other Member
States have refused it, one of the Member States                                 States have refused it, one of the Member States
concerned or the Commission may refer the matter to                              concerned, the Commission or the person responsible for
the Committee for application of the procedure referred                          placing the product on the market may refer the matter
to in Article 21.                                                                to the Committee for application of the procedure
                                                                                 referred to in Articles 21 and 22.
                                                      Subparagraphs 2 and 3 unchanged
                                                  The rest of Article 1 (11) is unchanged
                                                    P a r a g r a p h s 12 t o 20 u n c h a n g e d
21. In Article 48, the first paragraph is replaced by the                        21. In Article 48, the first paragraph is replaced by the
     following:                                                                        following:
     'The inclusion of a package insert in the packaging                               'The inclusion of a package insert in the packaging
     of veterinary medicinal products shall be obligatory                              of veterinary medicinal products shall be obligatory
     unless all the information required by this Article can                           unless all the information required by this Article can
     be conveyed on the packaging itself. Member States                                be conveyed on the packaging itself. Member States
     shall take all appropriate measures to ensure that the                            shall take all appropriate measures to ensure that the
     information included on the package insert of a                                   information included on the package insert of a
    veterinary medicinal product relates solely to the                                 veterinary medicinal product relates solely to the
    veterinary medicinal product concerned.'                                           veterinary medicinal product concerned. It shall be
                                                                                       written in one of the languages of the Member State
                                                                                       in which the medicinal product is marketed.'
                                                    P a r a g r a p h s 22 t o 23 u n c h a n g e d
                          P a r a g r a p h 24 ( D i r e c t i v e 8 1 / 8 5 1 / E E C A r t i c l e 51) u n c h a n g e d
                                                   Article 52, subparagraph 1 unchanged
                                       Article 52, subparagraph 2, points (a) to (f) unchanged
(g) name and address of the prescribing veterinarian, if                         (g) name and address of the prescribing veterinarian,
    any, date of the prescription.                                                     date of the prescription and the contents of the
                                                                                       veterinary prescription.
 ---pagebreak---  N o C 131/20                        Official Journal of the European Communities                                     30. 5. 90
                       ORIGINAL TEXT                                                          AMENDED TEXT
                                         The rest of paragraph 24 is unchanged
                                                P a r a g r a p h 25 u n c h a n g e d
                                             A r t i c l e s 2 and 3 u n c h a n g e d
             Proposal for a Council Directive extending the scope of Directive 81/851/EEC on the approxi-
             mation of the laws of the Member States relating to veterinary medicinal products and laying
                     down additional provisions for immunological veterinary medicinal products (')
                                             COM(90) 135 final — SYN 190
                (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 4 May 1990)
                                                            (90/C 131/07)
             0) OJ No C 61, 10. 3. 1989, p. 20 (COM(88) 779 final — SYN 190).
                       ORIGINAL TEXT                                                         AMENDED TEXT
                                            Visas and recitals unchanged
                         Article 1                                                              Article 1
                                          P a r a g r a p h s 1 and 2 u n c h a n g e d
3.    This Directive and Directive 81/851/EEC shall not               3.     This Directive and Directive 81/851/EEC shall not
apply to autogenous vaccines which are manufactured                   apply to inactivated immunological veterinary medicinal
from organisms found in discharges from the body of an                products which are manufactured from pathogens and
animal and used for the treatment of the individual                   antigens obtained from an animal or from a holding and
animal from which the organisms are derived.                          used for the treatment of that animal or the animals of
                                                                      that holding in the same locality.
                                                  T h e r e s t is u n c h a n g e d