Specific shelf life request at the entrance of the country

For some countries, there is a legal obligation to provide a specifi shelf life in order to import medical products.

The purpose of this service sheet is to give the possibility to missions with legal obligation to be able to obtain a specific lifetime for certain items, a determined lifetime and/or a minimum lifetime (ex: minimum 6 month of lifespan on entry into the country).

The aim of the document is to describe 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 requests done by the authorities. It is necessary to negotiate with them beforehand to avoid generating work and blockages when supplying products. Prejudicial precedents can be set for other sections, European Supply Centers and NGOs if new requirements are not well investigated and validated.

When the request for specific shelf life is validated, MSF Supply undertakes to provide these items under the conditions below.

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 all medical and non-medical products tracked by batch and lifetime by the manufacturer.

Out of scope :

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

• Short shelf life items

• Articles for donation (MSF order treated by MSF-Supply and given to another mission).

• Dex File articles.

Side note : The list of articles and kits with a very short lifespan (≤ 24 month) is available on the website extranet.msfsupply.be under the tab research / short shelf life

1. 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.

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 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.MSF-Supply :

The feasibility of the demand will then be analyzed internally at MSF-Supply. The articles availability will be conditioned by the in stocked articles lifespan and our suppliers lifespan. This may result in longer delivery times for these items.

2.5 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).

#

Name

Conditions/Limits

1

Order > 1000 articles

Yes, but the treatment delay takes longer than usual

2

Order with FIFO stocked articles

Yes, if approve in the agreement

3

For OC and partners only

Yes, No longer delay for partners than for the MSF mission