NoC 131/16 Official Journal of the European Communities 30. 5. 90 
ORIGINAL TEXT AMENDED TEXT 
4.4. National maximum residue limits. ANNEX V 
Points 1 to 4.3 unchanged 
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 81/851/EEC, Article 1 (5)) subparagraphs 1 and 2 
unchanged 
2. Before the date of implementation of this Directive, 
Member States shall communicate to the Commission a 
list of the veterinary medicinal products which are 
available without veterinary prescription. 2. Before the date of implementation of this Directive, 
Member States shall communicate to the Commission a 
list of the veterinary medicinal products which are 
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 
Paragraph 4 (Directive 81/851/EEC, Article 4) subparagraph 1 unchanged 
30. 5. 90 Official Journal of the European Communities NoC 131/17 
ORIGINAL TEXT AMENDED TEXT 
2. No veterinary medicinal product may be admin­
istered to animals unless the authorization referred to 
above has been issued, except for the tests of veterinary 
medicinal products referred to in point 10 of Article 5 
which have been notified to or approved by the 
competent national authorities in accordance with the 
national rules in force. 2. No veterinary medicinal product may be admin­
istered to animals unless the authorization referred to 
above has been issued, except for the tests of veterinary 
medicinal products referred to in point 10 of Article 5 
which have been notified to or approved by the 
competent national authorities in accordance with the 
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 81/851/EEC, Article 5) subparagraphs 1 to 10 
unchanged 
11. a summary in accordance with Article 5a of the 
product characteristics, one or more specimens or 
mock-ups of the sales presentation of the veterinary 
medicinal product together with a package insert 
where one is to be enclosed. 11. a summary in accordance with Article 5a of the 
product characteristics, one or more specimens or 
mock-ups of the sales presentation of the veterinary 
medicinal product together with a package insert (six 
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. 
NoC 131/18 Official Journal of the European Communities 30. 5. 90 
ORIGINAL TEXT AMENDED TEXT 
Paragraph 6 (Article 5a of Directive 81/851/EEC) subparagraphs 1 to 4 
unchanged 
Subparagraph 5.0. unchanged 
5.1. Therapeutic indications, specifying the target 
species. 5.1. Therapeutic indications specifying the target 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 
Paragraphs 7 to 10 unchanged 
Paragraph 11 (Directive 81/851/EEC, Article 16) subparagraphs 1 and 2 
unchanged 
3. The Committee shall draw up its own rules of 
procedure. 3. The Committee shall draw up its own rules of 
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 (Directive 81/851/EEC, Article 17) subparagraphs 1 and 2 
unchanged 
3. The holder of the marketing authorization shall 
notify the dates on which the dossiers were sent to the 
Member States concerned. As soon as the Committee has 
noted that all the Member States concerned are in 
possession of the dossier, it shall forthwith inform all the 
Member States and the applicant of the date on which 
the last Member States concerned received the dossier. 
The Member State(s) concerned shall either grant the 
authorization valid for their markets within a period of 
120 days of the aforementioned date, taking into due 
consideration the authorization issued within the 
meaning of paragraph 1, or put forward a reasoned 
objection. 3. The holder of the marketing authorization shall 
notify the Committee the dates on which the dossiers 
were sent to the Member States concerned. The Member 
States shall immediately inform the Committee and the 
person responsible for placing the product on the market 
that they have received the dossier. 
As soon as the Committee has noted that all the Member 
States concerned are in possession of the dossier, it shall 
forthwith inform all the Member States and the applicant 
of the date on which the last Member States concerned 
received the dossier. The Member State(s) concerned 
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. 
30. 5. 90 Official Journal of the European Communities NoC 131/19 
ORIGINAL TEXT AMENDED TEXT 
Paragraph 11 (Directive 81/851/EEC, Article 18) subparagraph 1 unchanged 
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 
If several applications submitted in accordance with 
Articles 5 and 5a have been made for a marketing 
authorization for a particular veterinary 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 or the Commission may refer the matter to 
the Committee for application of the procedure referred 
to in Article 21. Article 19 
If several applications submitted in accordance with 
Article 5 and 5a have been made for a marketing 
authorization for a particular veterinary 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, the Commission or the person responsible for 
placing the product on the market may refer the matter 
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 
Paragraphs 12 to 20 unchanged 
21. In Article 48, the first paragraph is replaced by the 
following: 
'The inclusion of a package insert in the packaging 
of veterinary medicinal products shall be obligatory 
unless all the information required by this Article can 
be conveyed on the packaging itself. Member States 
shall take all appropriate measures to ensure that the 
information included on the package insert of a 
veterinary medicinal product relates solely to the 
veterinary medicinal product concerned.' 21. In Article 48, the first paragraph is replaced by the 
following: 
'The inclusion of a package insert in the packaging 
of veterinary medicinal products shall be obligatory 
unless all the information required by this Article can 
be conveyed on the packaging itself. Member States 
shall take all appropriate measures to ensure that the 
information included on the package insert of a 
veterinary medicinal product relates solely to the 
veterinary medicinal product concerned. It shall be 
written in one of the languages of the Member State 
in which the medicinal product is marketed.' 
Paragraphs 22 to 23 unchanged 
Paragraph 24 (Directive 81/851/EEC Article 51) unchanged 
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. 
NoC 131/20 Official Journal of the European Communities 30. 5. 90 
ORIGINAL TEXT AMENDED TEXT 
The rest of paragraph 24 is unchanged 
Paragraph 25 unchanged 
Articles 2 and 3 unchanged 
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 
Paragraphs 1 and 2 unchanged 
3. This Directive and Directive 81/851/EEC shall not 
apply to autogenous vaccines which are manufactured 
from organisms found in discharges from the body of an 
animal and used for the treatment of the individual 
animal from which the organisms are derived. 3. This Directive and Directive 81/851/EEC shall not 
apply to inactivated immunological veterinary medicinal 
products which are manufactured from pathogens and 
antigens obtained from an animal or from a holding and 
used for the treatment of that animal or the animals of 
that holding in the same locality. 
The rest is unchanged