The information mentioned in 1° to 3° of article R. 5138-1, with the exception of the name of the establishment’s legal representatives, is entered in the European Union database.
The declaration provided for in Article L. 5138-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the company to which the establishment belongs, by any means enabling receipt to be acknowledged. It includes the following information: 1° The name or corporate name and address of the company to which the establishment belongs and the address of the…
The descriptive file provided for in Article L. 5138-1 and accompanying the declaration shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of acknowledging receipt. It includes the following information 1° Administrative information relating to the establishment where the activity of manufacturing, importing or distributing excipients is carried out, its internal organisation and, where applicable, its other activities and…
The certificate of compliance with good manufacturing practice referred to in article L. 5138-4 is issued following an inspection of the establishment if the good practices provided for in article L. 5138-3 are complied with. This certificate may not be used to guarantee the purity or quality of individual batches of products manufactured. It is issued within ninety days of the inspection. If no response is received from the Agency…
The application for the certificate provided for in the second paragraph of Article L. 5138-4 is sent to the Agence nationale de sécurité du médicament et des produits de santé by a person authorised to bind the establishment.
When the inspection reveals that the manufacture or repackaging and relabelling carried out in the context of the distribution of a raw material for pharmaceutical use does not comply with the good practices provided for in Article L. 5138-3, the inspected establishment shall immediately inform the manufacturers of the medicinal products in which this raw material is used. If a certificate has previously been issued to this establishment, the Director…
The Agence nationale de sécurité du médicament et des produits de santé shall transmit to the European Medicines Agency, for recording in the Community database, the certificates of good manufacturing practice that it issues. Where an inspection reveals non-compliance with good manufacturing practice, this information is also transmitted for recording in the Community database.
Active substances may only be imported for the manufacture of medicinal products for human use from a third country into the European Union if they are accompanied by written confirmation from the competent authority of the exporting third country that: 1° The standards of good manufacturing practice applicable to the establishment manufacturing the exported active substances are at least equivalent to those defined by the European Union; 2° The manufacturing…
The written confirmation referred to in article R. 5138-7 is not required when the active substances imported come from a country on the list provided for in article 111b of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
Exceptionally and where necessary, in order to ensure the availability of medicinal products, where a manufacturing establishment of an active substance intended for export and located in a third country has been inspected by a Member State and found to comply with the principles and guidelines of good manufacturing practice, the requirement referred to in Article R. 5138-7 may be waived for a period not exceeding the validity of the…
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75001, Paris France
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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