Specific labelling/notice language need at the entrance of the country

For some countries, there is a legal obligation to provide specific languages for labelling or notice in order to import medical products.

The purpose of this service sheet is to define the conditions under which MSF Supply is able to provide these specific labelling/notice languages. It also describes the application and validation process to ensure that these requests are well-founded.

It is essential to check the relevance of the request by the authorities. It is necessary to negotiate with them beforehand to avoid generating unnecessary work and blockages when supplying products. Prejudicial precedents can be set for other sections, European Supply Centers and NGOs if requirement are not investigated and validated correctly.

When the request for specific language labelling/notice is validated, MSF Supply undertakes to provide them. If they 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.

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.

At the international level there are not sources in all the languages required by MSF. The main languages are French and English.

1. Before contacting MSF Supply, 2 preliminary steps are necessary :

1.1 Any new request for specific labelling/notice language 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.

1. 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

• 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).