...
For some countries, there is a legal obligation to provide a series of documents in order to import medical products. the aim is to regulate their entry into the country and to ensure their quality. The list of documents requested from the countries is growing and MSFSupply is making every effort to make them available. The purpose of this service sheet is to describe these documents and to define the conditions under which MSF Supply is able to provide them. It also describes the application and validation process to ensure that these requests are well-founded. It is essential to check the relevance of these documents requested by the authorities. It is necessary to negotiate with them beforehand to avoid generating unnecessary documentation, work and blockages when supplying products. Prejudicial precedents can be set for other sections, European Supply Centers and NGOs if new documents are accepted too easily. When the request for documents is validated, MSF Supply undertakes to provide these documents. If the documents are not available, MSF Supply undertakes to find a suitable alternative solution (e.g. new sources, other document....), inform the mission and share possible options. It is strongly recommended for countries with high import constraints to provide standard lists of products to MSF-Supply to be able to anticipate the orders and to find alternative sources. Otherwise the order processing time might be impacted by the request. |
2. Scope
This service concerns medical products: Drugs and medical devices |
...
# | Nom | Abb | Definition / explanation | Conditions / limits |
1 | Certificate of Origin | CoO | Document containing the freight file number, packaging number, code, description, quantity, batch, manufacturer, country of origin, etc. | Internal document prepared by MSF Supply Only available for products tracked by batch
|
2 | Certificate of Analysis | CoA | Document containing the results of the identity and quality controls of the batch produced by the manufacturer | Documents not always available, for
|
3 | Quality Attestation | Att | A certificate from the MSF Supply Pharmacist responsible assuring that the product has undergone and passed a quality control. | A Att can be delivered if the CoA is not available. Not all countries accept it.
|
4 | Certificate of Pharmaceutical Products | CPP | Document indicating the status of the product in the exporting country. Proof that the product is registered (or not) in the country of origin. Applies to only one product. | Documents not always available, for
|
5 | Market AuthorisationAuthorization | AMMMA | Document mentioning the agreement given to a holder of the exploitation rights of a medicinal product so that he can commercialise it. Proof that the product is registered in the country of origin. Applies to only one product. | Documents not always available, for
|
6 | Certificate of Licence State | CLS | Document issued by the competent authority only in the UK Proof that the product is registered in the country of origin (UK) | Documents not always available, for
|
7 | Summary Lot Protocol | SLP | Document edited by the manufacturer It contains the results of the tests carried out, the composition of the vaccines, the certificates of analysis and the different stages of manufacture of the batch concerned. | Documents not always available, for
|
8 | Batch Release Certificate | BRC | Document edited by the authorities The SLP is submitted to the authorities in the country of manufacture who compare it to the template associated with the vaccine and verify that the SLP results are in compliance. The authorities issue the BRC, which is the official batch release. | Documents not always available, for
|
9 | Certificate of Sterility | CoS | Document edited by the manufacturer It certifies that the batch produced is sterile | Documents not always available, for
A CoA or a CoC can replace it if the sterility test in mentioned inside. |
10 | Declaration or Certificate of conformity | DoC or CoC | Self-declaration by the manufacturer concerning the conformity of its products with European requirements. It only concerns low class MDs. For high class MDs, the DoC is replaced by the CE certificate | For low class Medical Devices |
11 | EC Certificate | Document edited by a Notified Body (NB) | For high class Medical Devices | |
12 | ISO 13485 Certificate | Document edited by a Notified Body (NB) | ||
13 | Specific certificates for therapeutic food | Certificate of conformity Phytosanitary certificate Certificate of Non-GMO Certificate of non-radioactivity Halal Certificate | For therapeutic food Very specific cases |
...