3. 12. 88 Official Journal of the European Communities No C 308/9 
II 
(Preparatory Acts) 
COMMISSION 
Amended proposal for a Council Directive amending Directives 65/65/EEC, 75/318/EEC and 
75/319/EEC on the approximation of provisions laid down by law, regulation or administrative 
action relating to proprietary medicinal products (') 
COM(88) 663 final — SYN 114 
(Submitted by the Commission pursuant to the third paragraph of Article 149 of the Treaty on 
11 November 1988) 
(88/C 308/07) 
0) OJ No C 36, 8. 2. 1988, p. 22. 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Title unchanged 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 
In cooperation with the European Parliament, 
Having regard to the opinion of the Economic and 
Social Committee, 
Whereas the essential aim of any rules governing the 
production, distribution or use of medicinal products 
must be to ensure a high level of protection of public 
health; 
"Whereas the directives on the approximation of the laws 
relating to proprietary medicinal products must be 
adapted to scientific progress and take account of the 
experience obtained since their adoption; 
Whereas, in its conclusions of 15 May 1987 on 
improvement in the use of proprietary medicinal 
products by the consumer (*),. the Council considered 
that the system for leaflets accompanying proprietary 
medicinal products, for human consumption, on the 
market in the Community should be improved; THE COUNCIL OF THE EUROPEAN COMMUNITIES, 
Visas unchanged 
First recital unchanged 
Whereas the directives on the approximation of the laws 
relating to proprietary medicinal products must be 
adapted to scientific progress and take account of the 
experience obtained since their adoption so as to ensure 
greater quality, safety and efficacy; 
Third to sixth recitals unchanged 
O OJ No C 178, 7. 7. 1987, p. 2. 
No C 308/10 Official Journal of the European Communities 3. 12. 88 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Whereas the guarantees of the quality of medicinal 
products manufactured within the Community should be 
maintained by requiring compliance with the principles 
of good manufacturing practice for medicinal products 
irrespective of the final destination of the products; 
Whereas the Commission should be empowered to 
define in detail the principles of good manufacturing 
practice for medicinal products in close cooperation with 
the Committee for Adaptation to Technical Progress of 
the Directives on the Removal of Technical Barriers in 
the Proprietary Medicinal Products Sector; 
Whereas having regard to the resolution of the European 
Parliament of 13 June 1986 on the export of pharma­
ceutical products to the Third World, measures should 
be taken to improve the provision of information for 
third countries about the conditions of use of medicinal 
products within the Member States; 
Whereas the scope of Directive 65/65/EEC (*), as last 
amended by Directive 87/21/EEC (2) and Second 
Directive 75/319/EEC (J), as last amended by Directive 
83/570/EEC (4), on the approximation of provisions laid 
down by law, regulation or administrative action relating 
to proprietary medicinal products should be extended to 
cover other ready-made medicinal products which do 
not comply with the definition of proprietary medicinal 
products; Whereas the scope of Directive 65/65/EEC, as last 
amended by Directive 87/21/EEC, and Second 
Directive 75/319/EEC, as last amended by Directive 
83/570/EEC, on the approximation of provisions laid 
down by law, regulation or administrative action relating 
to proprietary medicinal products should be extended to 
cover other industrially manufactured medicinal products 
hitherto excluded; 
Whereas in the Community directives relating to 
medicinal products the word 'therapeutic' should be 
understood as covering all the medicinal purposes for 
which a medicinal product may be administered to 
human beings or animals, which may be to prevent or 
treat disease, to make a medical diagnosis or to restore, 
correct or modify physiological functions, Eight recital deleted 
HAS ADOPTED THIS DIRECTIVE: HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Council Directive 65/65/EEC of 26 January 1965 on the 
approximation of provisions laid down by law, regulation 
or administrative action relating to proprietary medicinal 
products is hereby amended as follows: Article 1 
Unchanged 
(') OJ No 22, 9. 2. 1965, p. 369/65. 
O OJ No L 15, 17. 1. 1987, p. 36. 
(3) OJ No L 147, 9. 6. 1975, p. 13. 
(4) OJ No L 332, 28. 11. 1983, p. 1. 
3. 12. 88 Official Journal of the European Communities No C 308/11 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
1. In Article 1, the following points 4 and 5 are inserted: 1. In Article 1, the following points 4 and 5 are inserted: 
'4. Ready-made medicinal product '4. Magistral formula: 
Any medicinal product prepared in advance which 
does not comply with the definition of proprietary 
medicinal products and which is marketed in a 
pharmaceutical form which may be used without 
further industrial processing. any medicinal product prepared in a pharmacy in 
accordance with a prescription for an individual patient. 
Therapeutic Official formula: 
The medicinal purpose for which a medicinal product 
is administered to human beings or animals, as 
specified in point 2.' any medicinal product prepared in a pharmacy in 
accordance with the prescriptions of a pharmacopoeia 
and which is intended to be supplied directly to the 
patients served by the pharmacy in question.' 
2. Article 2 is amended as follows: 2. Article 2 is amended as follows: 
'The provisions of Chapters II to V shall apply to 
medicinal products for human use intended to be 
placed on the market in Member States in the form of 
proprietary medicinal products or ready-made 
medicinal products to the exclusion of medicinal 
products which are prepared extemporaneously in an 
individual pharmacy for individual patients.' '1. The provisions of Chapters II to V shall apply 
to proprietary medicinal products for human use 
intended to be placed on the market in Member 
States. 
2. Where a Member State authorizes the placing on 
the market of industrially produced medicinal products 
which do not comply with the definition of a 
proprietary medicinal product, it shall also apply the 
provisions of Chapters II to V to them. 
3. The provisions of Chapters II to V shall not 
apply to: 
— medicinal products prepared on the basis of a 
magistral or officinal formula, 
— medicinal products intended for research and 
development trials, 
— intermediate products intended for further 
processing by an authorized manufacturer. 
4. A Member State may, in accordance with legis­
lation in force and to satisfy special needs, exclude 
from the provisions of Chapters II to V medicinal 
products supplied in response to a genuine unsolicited 
order, formulated in accordance with the specifications 
of an authorized health care professional for use by his 
individual patients on his direct personal responsi­
bility.' 
3. In the title, preamble and Chapters II to V all 
references to 'proprietary medicinal product' or to 
'proprietary product' are replaced by 'medicinal 
product'. 3. Unchanged 
No C 308/12 Official Journal of the European Communities 3. 12. 88 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
4. In Article 4a, the following point 6.6 is inserted: 
'6.6. special precautions for disposal of unused 
product or waste materials, if appropriate.' 4. In Article 4a, the following point 6.6 is inserted: 
'6.6. special precautions for disposal of unused 
products or waste materials derived from the 
products, if appropriate.' 
5. In Article 13, the following point 9 is inserted: 
'9. special precautions for disposal of unused product 
or waste materials, if any.' 5. In Article 13, the following point 9 is inserted: 
'9. special precautions for disposal of unused 
products or waste materials derived from the 
products, if any.' 
6. In Article 14, the following fifth indent is added: 
'— manufacturer's batch number.' 6. Unchanged 
Article 2 
In Council Directive 75/318/EEC of 20 May 1975 on 
the approximation of the laws of Member States relating 
to analytical, pharmaco-toxicological and clinical 
standards and protocols in respect of the testing of 
proprietary medicinal products, all references to 
'proprietary medicinal product' or to 'proprietary 
product' shall be replaced by 'medicinal product'. Article 2 
Unchanged 
Article 3 
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 is hereby amended as follows: Article 3 
Unchanged 
1. In Article 4, the text of paragraph (b) is amended as 
follows: 1. In Article 4, the text of paragraph (b) is amended as 
follows: 
'(b) may submit the medicinal product, its active 
principles or other constituent materials for 
testing by a State laboratory or by a laboratory 
designated for that purposes 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.' '(b) may submit the medicinal product, its starting 
materials and if necessary intermediate products, 
or other constituent materials 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.' 
2. In Article 6, the last paragraph is replaced by the 
following: 
'The inclusion of a package leaflet in the packaging 
of "over the counter medicinal products" shall be 
obligatory unless all the information required by this 
Article can be conveyed on the packaging itself. 2. In Article 6, the last paragraph is amended as 
follows: 
'The inclusion of a package leaflet in the packaging 
of medicinal products shall be obligatory unless all 
the information required by this Article can be 
conveyed on the container and the external 
packaging.' 
3. 12. 88 Official Journal of the European Communities No C 308/13 
ORIGINAL PROPOSAL 
For the purposes of this Article, "over the counter 
medicinal products" are those medicinal products 
which are placed on the market with a view of their 
direct sale to the public, without the need for a 
medical prescription, for use in the relief of minor 
illnesses not requiring a medical diagnosis. 
In the case of other medicinal products, Member 
States may require that a leaflet be included with the 
packaging. 
Within two years of the date of the adoption of this 
Directive, the Commission shall present to the 
Council a report on the possibility of making more 
systematic the use, and more legible and intelligible 
the content, of package leaflets, accompanied if 
appropriate by suitable proposals.' 
3. Article 16 (1) is amended as follows: 
'1. Member States shall take all appropriate 
measures to ensure that the manufacture of 
medicinal products is subject to the holding of an 
authorization. This manufacturing authorization 
shall be required notwithstanding that the medicinal 
products manufactured are intended for export'. 
4. The following Article 16a is inserted: 
'Article 16a 
1. At the request of the manufacturer or the auth­
orities of a recipient country, Member States shall 
certify that a manufacturer of medicinal products is 
in possession of the authorization referred to in 
paragraph 1 of Article 16. When issuing such 
certificates, Member States shall have regard to the 
prevailing administrative arrangements of the World 
Health Organization. 
2. The summary of the product characteristics 
approved by the Member State in accordance with 
Article 4b of Directive 65/65/EEC shall be annexed 
to the certificate. 
3. When the manufacturer is not in possession of 
a marketing authorization in the country of origin, 
he must provide the authorities responsible for estab­
lishing the certificate referred to in paragraph 1 with 
a declaration explaining why no marketing auth­
orization has been obtained.' AMENDED PROPOSAL 
3. Unchanged 
4. The following Article 16a is inserted: 
'Article 16a 
At the request of the manufacturer, the exporter or 
the authorities of an importing third country, 
Member States shall certify that a manufacturer of 
medicinal products is in possession of the auth­
orization referred to in Article 16 (1). When issuing 
such certificates, they shall comply with the following 
conditions: 
1. Member States shall have regard to the prevailing 
administrative arrangements of the World Health 
Organization. 
2. For medicinal products intended for export which 
are already authorized on their territory, they 
shall supply the summary of the product charac­
teristics as approved in accordance with Article 4b 
of Directive 65/65/EEC. 
3. When the manufacturer is not in possession of a 
marketing authorization, he shall provide the 
authorities responsible for establishing the 
certificate referred to in paragraph 1 with a 
declaration explaining why no marketing auth­
orization is available.' 
NoC 308/14 Official Journal of the European Communities 3. 12. 88 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
5. In Article 17, the following paragraph (d) is inserted: 5. In Article 19, the following paragraph (f) is inserted: 
'(d) demonstrate that he complies with the principles 
of Good Manufacturing Practices for medicinal 
products laid down by Community law.' '(f) to comply with the principies and the guidelines 
of good manufacturing practice for medicinal 
products laid down by Community law.' 
6. The following Article 17a is inserted: 
'Article 17a 6. The following Article 19a is inserted: 
'Article 19a 
The principles of good manufacturing practices for 
medicinal products referred to in Article 17, 
paragraph (d) shall be adopted, in the form of a 
directive addressed to Member States, in accordance 
with the procedure laid down in Article 2c of 
Directive 75/318/EEC The principles and guidelines of good manufacturing 
practice for medicinal products referred to in Article 
19 (f) shall be adopted, in the form of a directive 
addressed to Member States, in accordance with the 
procedure laid down in Article 2c of Directive 
75/318/EEC; detailed guidelines shall be published 
by the Commission and revised as appropriate to take 
into consideration scientific and technical progress.' 
7. In the second paragraph of Article 26, the following 
subparagraph (d) is inserted: 
'(d) report periodically to the competent authorities 
on whether the manufacturer complies with the 
principles of good manufacturing practices for 
medicinal products laid down by Community 
law.' 7. In Article 26: 
the first paragraph is amended as follows: 
'The competent authority of the Member State 
concerned shall ensure by means of repeated 
inspections that the legal requirements relating to 
proprietary medicinal products are complied 
with.' 
— the following third paragraph is inserted: 
'The officials representing the competent 
authority shall report after each of the inspections 
mentioned in the first paragraph on whether the 
manufacturer complies with the principles and 
guidelines of good manufacturing practice laid 
down by Community law. The manufacturer 
shall be informed of the content of such reports 
and shall be able to demand a second inspection.' 
In Article 30, the following second paragraph is 
inserted : In Article 30, the following second paragraph is 
inserted : 
'Upon request, Member States shall forthwith 
communicate the reports referred to in subparagraph 
(d) of the second paragraph of Article 26 to the 
competent authorities of another Member State. If, 
after considering the reports, the Member State 
receiving the reports considers that it cannot accept 
the conclusions reached by the competent authority 
of the Member State in which the report was estab­
lished, it shall inform the competent authority 
concerned of its reasons and may request that a 
further inspection of the manufacturing estab­
lishment be carried out. If the Member States 
concerned are unable to reach agreement, they shall 
forthwith inform the Commission.' 'Upon reasoned request, Member States shall 
forthwith communicate the reports referred to in the 
third paragraph of Article 26 to the competent auth­
orities of another Member State. If, after considering 
the reports, the Member State receiving the reports 
considers that it cannot accept the conclusions 
reached by the competent authority of the Member 
State in which the report was established, it shall 
inform the competent authority concerned of its 
reasons and may request further information. In the 
case of prolonged disagreement between Member 
States, the Member State(s) shall inform the 
Commission.' 
3. 12. 88 Official Journal of the European Communities No C 308/15 
ORIGINAL PROPOSAL 
9. The following paragraphs 2 and 3 are added to 
Article 33: 
'2. The person responsible for the marketing of a 
medicinal product shall be obliged to notify the 
Member States forthwith of any action taken by him 
to suspend the marketing of a product or to 
withdraw a product from the market, together with 
the reasons for such action. Member States shall 
ensure that this information is brought to the 
attention of the Committee forthwith. 
3. Member States shall ensure that appropriate 
information about actions taken pursuant to para­
graphs 1 and 2 which may effect the protection of 
public health in third countries is forthwith brought 
to the attention of the World Health Organization 
with a copy to the Committee.' 
10. The first paragraph of Article 34 is hereby amended 
as follows: 
'This Directive shall apply to medicinal products for 
human use in the form of proprietary medicinal 
products or ready-made medicinal products to the 
exclusion of medicinal products which are prepared 
extemporaneously in an individual pharmacy for 
individual patients.' 
11. With the exception of the first paragraph of Article 
34, all references to 'proprietary medicinal product' 
or to 'proprietary product' shall be replaced by 
'medicinal product'. 
Article 4 
1. Member States shall take the measures necessary to 
comply with this Directive not later than 1 January 1991. 
They shall forthwith inform the Commission thereof. 
2. Requests for marketing authorization lodged after 
the time limit referred to in the first paragraph must 
comply with the provisions of this Directive. 
3. Articles 1, 2 and 3 of this Directive, where relevant, 
shall be progressively extended to existing medicinal 
products before 31 December 1992. 
Article 5 
This Directive is addressed to the Member States. AMENDED PROPOSAL 
9. The following paragraphs 2, 3 and 4 are added to 
Article 33: 
'2. The person responsible for the marketing of a 
medicinal product shall be obliged to notify the 
concerned Member States forthwith of any action 
taken by him to suspend the marketing of a 
medicinal product or to withdraw it from the market 
together with the reasons for such action. Member 
States shall ensure that this information is brought to 
the attention of the committee forthwith. 
3. Unchanged 
4. The Commission shall publish an annual list of 
medicinal products prohibited in the Community or 
subject to special restrictions in more than three 
Member States.' 
10. The first paragraph of Article 34 is hereby amended 
as follows: 
'This Directive shall apply to medicinal products for 
human use within the limits mentioned in Article 2 of 
Directive 65/65/EEC, as amended.' 
11. Deleted 
Article 4 
Unchanged 
Article 5 
Unchanged