Specific labelling/notice language need at the entrance of the country
Description of the service
1. Objective
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. |
2. Scope
This service concerns medical products: Drugs and medical devices At the international level there are not sources in all the languages required by MSF. The main languages are French and English. |
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Use of the service
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.
2.1.The mission Supply Co :
2.2 The OP desk :
2.3. The International Regulatory Affairs Pharmacist :
2.4.The desk OP :
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Conditions
MSF Supply provides the same service to MSF and its external client partners. |
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In case of any question, please contact your Desk OP