On the basis of good practices it shall draw up guidelines and standards for the selection, monitoring and assessment of public-private partnership projects.

"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.

"(f) comply with the principles and the guidelines on good manufacturing practice for medicinal products and use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.";

in Article 47, the following paragraphs shall be added:"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines.

in Article 51, the following paragraphs shall be added:"The principles of good manufacturing practice as regards the manufacturing of active substances for use as starting materials as referred to in Article 50(f) shall be adopted in the form of detailed guidelines.

Such assistance may include aiding the Commission and Member States to develop technical guidelines on good practice and on protective measures to be taken in response to human health threats, providing expert assistance and mobilising and coordinating investigation teams.

The competent authority may also carry out unannounced inspections at the premises of manufacturers of active substances used as starting materials, or at the premises of marketing authorisation holders whenever it considers that there are grounds for suspecting non-compliance with the principles and guidelines of good manufacturing practice referred to in Article 47.

Where the guides to good hygiene practice referred to in paragraph 1 are developed, they shall be developed as follows:

Guidelines on Good Distribution Practice of medicinal products for human use (94/C 63/03)

the need for the producing establishment to be in full conformity with the guidelines for good manufacturing practices (GMP);

whereas this Directive does not therefore impose observance of guides to good hygiene practice, which have no legal force;

In developing the European guides to good hygiene practice referred to in paragraph 6, all necessary measures shall be taken in order to:

In doing so, due consideration shall be given to the guides to good hygiene practice referred to in Article 5 of this Directive, where they exist.

comply with the principles and the guidelines of good manufacturing practice for medicinal products laid down by Community law;

ensure that the relevant guides to good hygiene practice drawn up in accordance with paragraphs 1 to 3 are taken into account,

Member States shall forward to the Commission those guides to good hygiene practice which they presume to comply with Article 3.

In the case provided for in Article 1 (2), this document may be the guide of good practice drawn up by the professional organization concerned.

Where expertise is not available in the establishment, advice should be obtained from other sources (consultancy, guides of good manufacturing practices, etc.).

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use

Member States shall assess the guides to good hygiene practice referred to in paragraphs 1 and 2 with a view to determining the extent to which they may be presumed to comply with Article 3.

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use and amendments thereto

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30)

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70)

Commission Directive of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (91/356/EEC)(OJL193,17.7.1991,p.30)

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ L 193, 17.7.1991, p. 30).

Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (OJ L 228, 17.8.1991, p. 70).

Commission Directive of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC) (OJL 228,17.8.1991, p. 70)

Whereas, in order to have the general rules of hygiene for foodstuffs and the guides to good hygiene practices implemented, the application of standards of the EN 29000 series should be recommended;

The titles and references of European guides to good hygiene practice developed in accordance with the procedure in paragraphs 6 and 7 shall be published in the C series of the Official Journal of the European Communities.

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (OJ No L 193, 17.7.1991, p. 30).

As part of the internal approach referred to in paragraph 1, establishments may use guides of good manufacturing practice drawn up by appropriate professional organizations and acceptable to the competent authorities.

Member States shall encourage the development of guides to good hygiene practice which may be used voluntarily by food businesses as a guide to compliance with the provisions of Article 3.

The principles and guidelines of good manufacturing practice for veterinary medicinal products referred to in Article 50(f) shall be adopted in the form of a Directive addressed to the Member States in accordance with the procedure referred to in Article 89(2).

Member States shall, if they consider it appropriate, recommend food business operators to apply the European Standards of the EN 29000 series in order to implement the general rules of hygiene and the guides to good hygiene practice.

Whereas the Commission, assisted by Member States and other interested parties, is to encourage the development of guides to good hygiene practice to which food businesses may refer where necessary throughout the Community;

Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (OJ L 262, 14.10.2003, p. 22)."

(2) Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use fn is to be incorporated into the Agreement.

Where one or more Member States, or the Commission, consider that, for the purposes of harmonization, there may be a need for guides to good hygiene practice to be developed on a European basis (hereafter referred to as 'European guides to good hygiene practice'), the Commission shall consult Member States in the framework of the Standing Committee on Foodstuffs in accordance with Article 14. The object of this consultation shall be to consider the case for such voluntary guides in the sectors or activities concerned, and, where such guides are considered necessary:

When not taken from regulatory standards (e. g. frozen storage temperature) or from existing and validated guides of good manufactoring practices, the team should ascertain their validity relative to the control of identified hazard and critical points.

Whereas Member States shall encourage and participate in the development of guides to good hygiene practice to which food businesses may refer, based, where appropriate, on the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius (4);

to comply with the principles and guidelines of good manufacturing practice for medicinal products as laid down by Community law.

they must comply with the principles and guidelines of good distribution practice for medicinal products as laid down in Article 84.

Relevant guides for good animal husbandry practices or other guidelines (mandatory or voluntary) defining at least:

Those principles and guidelines are set out in Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use(3).

"(f) to comply with the principles and guidelines of good manufacturing practice for medicinal products and to use as starting materials only active substances, which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.

The principles and guidelines of good manufacturing practices for medicinal products referred to in Article 46(f) shall be adopted in the form of a directive, in accordance with the procedure referred to in Article 121(2).

The CVMP concluded that according to “ current” GCP requirements this pivotal study design has many deficiencies.

COMMISSION DIRECTIVE of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products (91/412/EEC)

As part of the system referred to in paragraph 1, operators of meat establishments may use guides to good practice that have been assessed by the competent authority.

"(f) comply with the principles and the guidelines on good manufacturing practice for medicinal products and use as starting materials only active substances which have been manufactured in accordance with the detailed guidelines on good manufacturing practice for starting materials.";