No C 36/22 Official Journal of the European Communities 8. 2. 88 
— Insolvente liquidatie na faillietverklaring van de kredietinstelling: 
— Law on bankruptcy of 30 September 1893 and amendments S 140, Articles 1 to 212 of Title I. 
— Competent authority: the Court. 
PORTUGAL 
— Rules governing the winding-up of banking institutions: 
— Article 11 et seq. of Decree Law No 30—689 of 27 August 1940. 
— Competent authority: Minister of Finance. 
— Liquidacao na sequencia de revojacao de autorizacao: 
— Competent authority: Minister of Finance. 
— Cooperative banks: 
— Articles 75 and 77 of Decree Law No 454 / 80 of 9 October 1980 which refer to the general rules governing 
the bankruptcy procedure. 
— Article 1245 et seq. of Chapter XV of Decree Law No 44/129 of 28 December 1961. 
— Sale of property: Article 882 et seq. 
UNITED KINGDOM 
— Compulsory winding-up (Insolvency Act 1986, Section 4). 
— Creditors' voluntary winding-up. 
— Corporate voluntary arrangements (Insolvency Act 1986, Section 1). 
— Corporate arrangements and reconstructions (Companies Act 1985, Section 13). 
For Building Societies (Building Societies Act 1986, Section 10): 
— Compulsory winding-up. 
— Creditors' voluntary winding-up. 
— Dissolution by consent of an appropriate majority of the society's members. 
Competent authority: judicial authority. 
Voluntary liquidation (Insolvency Act 1986, Section 4). 
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(87) 697 final 
(Submitted by the Commission to the Council on 12 January 1988) 
(88/C 36/02) 
THE COUNCIL OF THE EUROPEAN COMMUNITIES, In cooperation with the European Parliament, 
Having regard to the Treaty establishing the European 
Economic Community, and in particular Article 100A 
thereof, 
Having regard to the proposal from the Commission, 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; 
8,2,88 Official journal of trie European Communities l^oC^/23 
whereas theDirectivesontheapproximationof the laws 
relating to proprietary medicinal products must be adapted 
to scientificprogress and tal^e account of the experience 
obtained since their adoptions 
whereas,mitsconclusionsofl5May 1987 onimprovement 
in the use of proprietary medicinal products by the 
consumers theCouncil considered that thesystemfor 
leaflets accompanying proprietary medicmalproducts,for 
human consumption, on the market in the Community 
should be improved^ 
whereas the guarantees of the quality of medicinal products 
manufactured within the Community should he 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^fechnical^rogressoftheDirectiveson the 
removal ofLechmcal earners in the proprietary Medicinal 
products sector, 
whereas, having regard to the resolution of the European 
parliament of 13]unel98^ on the export of pharmaceutical 
products to thefhird^orld,measures should betaken to 
improve theprovision of information for thirdcountnes 
about the conditions of use of medicinal products within the 
Member ^tates^ 
whereas the scope of Directive ^5/^5/EEC^, as last 
amended by Directive 87/21/EECO^,and second Directive 
75/319/EEC^, as last amended by Directive 
83/570/EECpEontheapproximationof 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, in the Community Directives relating to medicinal 
products, the word'therapeutic'shouldbeunderstoodas 
covering all the medicinal purposes for whichamedicmal 
product may be administered to human beings or animals, 
which may be to prevent or treat disease,to mal^eamedical 
diagnosis or to restore, correct or modify physiological 
functions, 
Council Directive ^5/^5/EEC of 2^ January 19^5 on the 
approximation ofprovisions laid down by law,regulation or 
administrative action relating to proprietary medicinal 
products is hereby amended as follows^ 
^oi^Der^,77n^7,D^ 
^01^DLt^r71 r^7,D^ 
^oi^Mcn^,^ t^,D r^ aoi^DL^^^ m ^^,D i 1, In Articlel,the following pomts^and5are inserted^ 
'^, ^^v^^^^^^^^^ro^^r 
Any medicinal product prepared in advance which 
does not comply withthe definition of proprietary 
medicinal products and which is marketed in a 
pharmaceutical form whichmaybeused without 
further industrial processing, 
5, ^^r^^^ 
I^hemedicmal purpose forwhichamedicmal product 
is administered to human beings or animals, as 
specified in pomt2' 
2 Article2is amended as follows 
'Idie provisions of Chapters H to V shall apply to 
medicinal products for human use intended to be placed 
on the market m Member states in the form of 
proprietarymedicmalproductsorreadyDmademedicmal 
products to the exclusion of medicinal products which 
are prepared extemporaneously in an individual 
pharmacy for individual patients,' 
3 In the title,preamble and ChaptersHtoVall references 
to 'proprietary medicinal product' or to 'proprietary 
product'are replaced by'medicinal product', 
^, In Articled,the following point D,Dis inserted^ 
'D,^ special precautions for disposal of unused product 
or waste materials, if appropriate,' 
5, In Article 13,the following pomt9is inserted^ 
'9, special precautions for disposal ofunused product or 
waste materials, if any,' 
D, In Article 1^, the following fifth indent is added^ 
'— manufacturer's batch number,' 
Ar^^2 
In Council Directive 75/318/EEC of 20 May 1975on the 
approximation of thelaws 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'propnetary medicinal 
product' or to 'proprietary product' are replaced by 
'medicinal product'. 
Ar^^^ 
Council Directive 75/319/EEC of 20 Mayl97^ on the 
approximation ofprovisions laid down by law, regulation or 
administrative action relating to proprietary medicinal 
products is hereby amended as follows^ 
No C 36/24 Official Journal of the European Communities 8. 2. 88 
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 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. 
For the purposes of this Article, "over the counter 
medicinal products" are those medicinal products 
which are placed on the market with a view to 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 
authorities of a recipient country, Member States shall 
certify that a manufacturer of medicinal products is in 
possession of the authorization referred to in Article 
16 (1). 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 
establishing the certificate referred to in paragraph 1 
with a declaration explaining why no marketing 
authorization has been obtained.' 
5. In Article 17, the following paragraph (d) is inserted: 
'(d) demostrate that he complies with the principles of 
Good Manufacturing Practices for medicinal 
products laid down by Community law.' 
6. The following Article 17a is inserted: 
'Article 17a 
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' 
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.' 
8. 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 established, it 
shall inform the competent authority concerned of its 
reasons and may request that a further inspection of the 
manufacturing establishment be carried out. If 
the Member States concerned are unable to reach 
agreement, they shall forthwith inform the 
Commission.' 
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. 
8. 2. 88 Official Journal of the European Communities No C 36/25 
3. Member States shall ensure that appropriate 
information about actions taken pursuant to 
paragraphs 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' are replaced by 'medicinal 
product'. 
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 disparities in the provisions laid down by law, 
regulation or administrative action by Member States may 
hinder trade in immunological products within the 
Community; 
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; 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 paragraph 1 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. 
Whereas the provisions laid down by Directive 
65/65/EEC (*), as last amended by Directive 
87/21/EEC (2), and Second Directive 75/319/EEC (3), 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, although appropriate, are inadequate for 
immunological medicinal products consisting of vaccines, 
toxins or serums and allergens; 
Whereas, in accordance with Article 5 of Directive 
87/22/EEC (5) on the approximation of national provisions 
relating to the placing on the market of high technology 
medicinal products, particularly those derived from 
biotechnology, the Commission is required to submit 
proposals to harmonize, along the lines of Directive 
75/319/EEC, the conditions for authorizing the 
manufacture and placing on the market of immunological 
medicinal products before 22 December 1987; 
(M OJ No 22, 9. 2. 1965, p. 369/65. 
(2) 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. 
(5) OJ No L 15, 17. 1. 1987, p. 38. Proposal for a Council Directive extending the scope of Directives 65/65/EEC and 75/319/EEC on 
the approximation of provisions laid down by law, regulation or administrative action relating to 
proprietary medicinal products and laying down additional provisions for immunological medicinal 
products consisting of vaccines, toxins or serums and allergens 
COM(87) 697 final 
(Submitted by the Commission to the Council on 12 January 1988) 
(88/C 36/03)