Response to pharmaceutical and medical documentation requirements

Description of the service

1. Objective

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 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
Out of scope :
Medical products in Kits. MSF Supply cannot commit to the entire documentation of the components of a kit.

Use of the service

Before contacting MSF Supply, 2 preliminary steps are necessary :

1.1 Any new request for documents must be a requirement of the competent authorities of the importing country.

1.2 This requirement must first be discussed, challenged and validated with the mission pharmacist or regional pharmacist.

2. Communication with MSF Supply:

2.1.The mission Supply Co :

Send an email to the desk OP (put in cc the mission pharmacist) in which :

Informs of the new request for documents

Attach to the email the official document from the competent authority (if possible)

2.2 The OP desk :

Ensures that the mission pharmacist has validated the request. If this is not the case, it sends an email back to the mission and asks to include the mission pharmacist in the discussion.

Return the request email to the International Regulatory Affairs pharmacist and cc the MSF Supply Regulatory Affairs pharmacist.

2.3. The International Regulatory Affairs Pharmacist :

Challenge the demand with the mission

Check with other Procurement Centers to see if these constraints have already been approved.

Checks with the pharmacist Regulatory Affairs of MSF Supply on the feasibility of the application

Validates (or not) the new request and informs by email the OP desk and the MSF Supply Regulatory Affairs pharmacist.

2.4.The desk OP :

Sends an e-mail to the mission Supply Co with the mission pharmacist in cc explaining the decision taken (validation or other decision).

Conditions

MSF Supply provides the same documentation to MSF and its external client partners. All new requests must be accompanied by an official document from the competent authority.

MSF Supply provides the same documentation to MSF and its external client partners. All new requests must be accompanied by an official document from the competent authority.

#	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 Medicines Vaccines included medical devices 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 Medicines Vaccines Some medical devices tracked by batch
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. Medicines
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 Medicines Vaccines
5	Market Authorization	MA	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 Medicines Vaccines
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 Medicines Vaccines
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 Vaccines
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 Vaccines
9	Certificate of Sterility	CoS	Document edited by the manufacturer It certifies that the batch produced is sterile	Documents not always available, for Sterile medical devices 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) A EC marked product meets certain technical standards and acquires the right of free movement throughout the EU. The EC marking is accompanied by a Certificate of Conformity. The EC certificate concerns high class MDs.	For high class Medical Devices
12	ISO 13485 Certificate		Document edited by a Notified Body (NB) ISO 13485 specifies the requirements for quality management systems (QMS) for the medical device industry.
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 Very rarely requested Managed only in case of specific needs of an assignment and on a case-by-case basis

In case of any question, please contact your Desk OP