Key Benefits:
The Director General of the French Health Products Safety Agency,
In light of the Directives 2001/82/EC and 2001/83/EC of the Parliament and Council of 6 November 2001 establishing a Community Code on Veterinary Drugs and a Community Code on Human-Use Drugs, as amended by the Directives 2004/27/EC and 2004/28/EC of the Parliament and the Council of 31 March 2004, together the Guide to Good Manufacturing Practices published by the European Commission;
In accordance with Commission Directive 2003/94/EC of 8 October 2003 establishing the principles and guidelines for the manufacture of human-use drugs and experimental human-use drugs;
Vu le Public Health Codeincluding articles L. 5121-5, L. 5124-1, L. 5138-1 and L. 5138-3;
Considering the opinion of the National Food, Environment and Labour Safety Agency of 27 July 2010;
Considering the successive amendments made to the principles of good manufacturing practices;
Considering that in order to improve the legibility of these principles and to facilitate their knowledge and good application by the operators, it is necessary to incorporate in a single document the good manufacturing practices of medicines as set out in the decision of 24 July 2009 and those relating to active substances mentioned in the decision of 6 July 2007 taking into account the division in two parts and the numbering of the annexes defined by the principles and guidelines of manufacture established by Directive 2003/94/EC;
Considering that, pending the transfer of the current amendments to the specific provisions on active substances currently contained in Part I and the annexes to the European Guide to Good Manufacturing Practices on Drugs, it is necessary to allow establishments that manufacture active substances, as a transitional measure, to comply with either the good manufacturing practices related to drugs or the good manufacturing practices relating to active substances and the provisions of the appropriate specific guidelines of good manufacturing practices relating to drugs,
Decides:
The principles of good manufacturing practices are defined in accordance with the provisions annexed to this decision.
The principles of good manufacturing practices of Part I, as annexed to this decision, are applicable to pharmaceutical establishments referred to inArticle L. 5124-1 of the Public Health Code. They also apply to the procurement, packaging, labelling and storage of experimental medicines carried out by pharmacists at the research sites authorized for these operations under the third paragraph of section L. 1121-13 of the same code.
The principles of good manufacturing practices of Part II, as annexed to this decision, are applicable to the establishments referred to inArticle L. 5138-1 of the Public Health Code engaged in the manufacture of active substances in the composition of drugs, including reconditioning and re-labelling for distribution.
As a transitional measure, until the amendment of the provisions relating to active substances in Part I annexed to this decision, which will accordingly intervene as a result of the amendment of Part I of the European Guide to Good Manufacturing Practices published by the European Commission pursuant to the above-mentioned Directives 2001/82/EC and 2001/83/EC, manufacturers of active substances may comply with either the good manufacturing practices relating to drugs or good practices
The decision of 6 July 2007 on good manufacturing practices for active substances and the decision of 24 July 2009 on good manufacturing practices are repealed.
The Director of Inspection and Institutions is responsible for the execution of this decision, which will be published in the Official Journal of the French Republic.
Done on 13 January 2011.
J. Marimbert
Note: This decision will appear, along with its annex, to the Official Bulletin of Social Protection and Solidarity of the Ministry of Labour, Employment and Health under the number 2011/8 bis.
