The French Minister of Solidarity and Health has signed a decree specifying how a small-scale pilot program will be supplied with medical cannabis that ultimately will be given to patients free of charge.
The decree, signed Friday, was followed by the Agency for the Safety of Medicines and Health Products (ANSM) publishing the application process for suppliers on Monday.
THE APPLICATION PROCESS
Conditions of participation and allocation
The call for candidates file compiled by the ANSM consists of the following documents:
- the participation and award conditions detailed in this document
- the specifications (10/19/2020) (333 kb) (annex to decree no. of October 18, 2020)
– part II listing the specifications and the controls expected to guarantee the quality of the medical cannabis supplied in the framework of the experiment;
– Part III relating to the modalities of delivery by the ANSM of authorizations relating to the experimentation of medical cannabis
Conditions of access to the file and modalities of exchanges with the ANSM
- When downloading the file from the ANSM website, potentially interested suppliers must inform ANSM of their interest, by email to the contacts mentioned in article VIII of the specifications. It is advisable to mention there the valid contact details of a correspondent of the company (name, first name, telephone number, professional e-mail address) in order to be able to communicate the results of the selection to him.
- The ANSM reserves the right to make, at the latest 6 days before the deadline fixed for the submission of proposals, detailed modifications or additional information included in the specifications. These modifications will not alter the substantial elements of the specifications and the conditions of participation. The ANSM will then submit information on its website in the section dedicated to the call for applications. Potential suppliers will then have to respond on the basis of the modified file without being able to raise any complaint.
- In accordance with the previous paragraph and once the documents have been downloaded, it is therefore the responsibility of the suppliers to communicate to the ANSM the valid contact details of at least one correspondent.
- It is the responsibility of potential suppliers to regularly consult the file available on the ANSM website in the section dedicated to questions relating to the call for applications, to check whether changes have been made to the file or whether questions and responses have been published.
- Potential suppliers are not allowed to make changes to the technical and administrative specifications prescribed in the above mentioned documents as part of their proposal. They must comply with all of the requirements
- To obtain any additional information that would be necessary for the establishment of their proposal, potential suppliers have the possibility to ask written questions throughout the selection procedure to the electronic address cahier email@example.com and within the timeframe indicated on the first page. No question asked outside of this channel and after this date will be taken into consideration.
- These questions will be the subject of answers available on the website in the section dedicated to questions relating to the call for applications no later than 6 days before the deadline set for receipt of proposals.
Period of validity of proposals
By submitting his offer, the supplier undertakes to maintain the terms of his proposal for the period of 5 months from the date of submission of the offers.
Conditions of participation – elements requested
- Potential suppliers are authorized to submit a proposal for one or more or even all of the lots listed in Article III 1) of the specifications. However, it is not possible to obtain all of the lots.
- In the event of a proposal for at least two lots, the supplier is required to submit a separate but complete file (all the documents and information required relating to the conformity criteria and the selection criteria) for each lot presented.
ATTENTION: The proposal must be written in French. Otherwise, it may be rejected.
The proposal file must be broken down into two parts, namely the elements requested under the compliance criteria on the one hand and the elements required under the selection criteria on the other hand (see below article “award conditions” and the technical response framework).
The participation file drafted by the potential suppliers consists of complete presentation elements on the stakeholders and the requirements related to the experiment as well as on the elements inherent in the medical cannabis used in the experiment (II) and on its mode of production (III):
- As part of his presentation, any participant is required to present in his response in an exhaustive manner the actors associated with the supply and distribution chain of medical cannabis, from the producer of raw material to the distributor, mentioning any processors and other intermediaries. The nature of the information required is specified in part II of the specifications as well as in the technical response framework.
- In terms of product requirements, it is up to each supplier to deliver a complete description of each form of medical cannabis that he wishes to supply (mode of production, processing, control procedures, characteristics of the varieties, etc.). Part II of the specifications and the technical response framework determine the areas of response expected and requiring to be developed in any proposal submitted by suppliers
- Finally, it is up to the supplier to detail his production methods. In particular, it will have to identify its production sites. Part II of the specifications and the technical response framework determine the response lines expected and requiring to be developed in any proposal submitted by suppliers.
- Samples (under the conditions described below)
Conditions of participation – samples requested
- In order to carry out a quality control of medical cannabis in the three months following the selection decision, candidates are asked to submit, during their bid, the mandatory samples, the list of which appears in part II of the specifications, each participant being required to sample all the references requested from the lot (s) for which he is participating in order to have his offer validated. One sample is requested for each lot presented.
- The samples will comply with the technical specifications stipulated in part II of the specifications. They must strictly correspond to what will be provided to patients during the experiment.
- Each form of medical cannabis and its associated vaporization device, if applicable, is delivered in its original commercial packaging and is labeled with the name of the medical cannabis, its commercial reference, the name of the supplier, and the batch number. to which it relates.
- The supplier may detail in a patient leaflet the optimal conditions of use of the sampled medical cannabis and of the vaporization device, if applicable. In any case, the samples provided are not subject to compensation.
- In addition, medical cannabis having a narcotic drug status, an import authorization relating to narcotics, issued by the ANSM, and an export authorization, issued by the competent authority of the country in which the medical cannabis is stored , must be obtained prior to the importation of samples of medical cannabis (EU or non-EU) according to the procedure described in part II of the specifications. It is therefore the supplier’s responsibility to initiate the steps as soon as possible to obtain said authorizations.
- The samples must be deposited against receipt or sent by post with acknowledgment of receipt no later than November 24, at 4.30 p.m. to the address indicated below:
Market surveillance center for chemical drugs and other health products
A l attention from Denis CHAUVEY
635, rue de la Garenne, 34748 Vendargues
- Compliance with the deposit of samples determines the validity of the offer. Failure to submit samples at the end of the time limits indicated above will constitute a reason for rejection of the candidate’s proposal.
- The samples will be shipped in a secure form in a very resistant container (packaging, packages, boxes or cases) guaranteeing perfect preservation of the contents and preventing damage or deterioration and supporting the conditions of transport and handling, anonymized and closed. The shipping conditions must respect the special conditions for storing samples, if applicable.
ANSM undertakes to destroy samples from unsuccessful suppliers.
Conditions for submitting proposals
- The envelope containing the response elements must be sent on paper:
– by registered letter with request for acknowledgment of receipt by post
– delivered directly to the ANSM (mail service building) against receipt, from Monday to Friday from 9 a.m. to 4:30 p.m.
- The supplier must include in the paper envelope three USB keys on which he will record all the constituent elements of his proposal. The transmission of these USB keys will allow the ANSM to facilitate simultaneous reading and analysis of documents.
The candidate sends his proposal (paper and USB keys) in a sealed envelope. The envelope must bear the following information:
|Selection of suppliers “Free supply and distribution of cannabis-based medicines for patients who will participate in the experimentation of the medical use of cannabis”
DO NOT OPEN
The proposal must reach the ANSM in accordance with the conditions prescribed above no later than November 24 at 4.30 p.m.
- At the stage of submitting proposals and samples, the simple submission of an offer and the corresponding samples constitutes a commitment by the supplier to his offer and implies unreserved acceptance of all the provisions of the specifications.
- The observed delay or the absence of the paper envelope containing the proposal within the time limit shall constitute rejection of the offer.
- Subsidiarily, suppliers are requested to send proposals electronically by sending an email to the following address (see article VIII of the specifications) firstname.lastname@example.org .
- Attachments should not exceed 20MB.
- Between these two mailings (paper and electronic), only the date of receipt of the paper envelope is valid.
- For all participants, a file per batch must be presented with all the elements required for the technical response. In the event that the supplier formulates an offer on several or on all the lots, he must indicate his order of preference insofar as it is not possible to obtain all the lots.
- In accordance with article IV of the specifications, the supplier must, in his offer, present a partnership concluded or under negotiation with an authorized pharmaceutical establishment located in France, having the status of operator and importer where applicable. applicable with proof of an authorization request for narcotics relating to medical cannabis within the framework of the experiment (according to the procedure described in part III of the specifications).
1 / In the event of a partnership concluded at the time of submission of the offer between the supplier and an operator, importer if applicable, to ensure the distribution of medical cannabis:
The supplier is invited to submit the following documents in support of his tender:
- the partnership certificate according to the model provided by ANSM, completed and signed by itself and by the operator;
- the authorization to open a pharmaceutical distribution establishment (operator);
- authorization to open an import pharmaceutical establishment, if applicable;
- an authorization request for narcotics relating to medical cannabis as part of the experiment with the ANSM (according to the procedure described in the appendix).
The absence of one of these documents when submitting the offer will result in the rejection of the latter.
2 / In the absence of a partnership concluded with an operator when submitting the offer:
The supplier is authorized to present his final partnership no later than December 15, 2020 at 4.30 p.m.
In this case, the supplier is invited to submit the date of submission of his offer:
- a sworn declaration, according to the model attached to the specifications, that he has actually entered into negotiations with an operator, importer if applicable;
- an authorization request for narcotics relating to medical cannabis in the context of the experiment, from the ANSM (according to the procedure described in the appendix).
The absence of one of these two documents when submitting the offer will result in the rejection of the offer.
Conditions for submitting proposals
- By December 15, 2020 (4.30 p.m.) at the latest, the supplier must submit the following documents:
- the partnership certificate according to the model provided by the ANSM, completed and signed by itself and by the operator
- authorization to open a pharmaceutical distribution establishment (operator)
- authorization to open an import pharmaceutical establishment, if applicable.
- In any event, the absence of a partnership certificate by December 15, 2020 (4.30 p.m.) at the latest will result in the rejection of the offer.
- The offer may also be rejected if the distributor does not have the status of operator, and importer if applicable on December 15, 2020 (4:30 p.m.).
ANSM reserves the right to verify these various authorizations.
1 / Initially, the submitted files are analyzed with regard to various compliance criteria selected and indicated in the technical response framework.
Compliance criteria have been retained for the following three fields:
- Requirements for stakeholder characteristics
- Requirements for the method of production of materials and finished products
- Requirements for finished products
Failure to comply with one of the compliance criteria set out in the technical response framework results in the proposal being eliminated and the analysis immediately stopped.
2 / Secondly and subject to compliance with the various compliance criteria, the files are assessed according to the criteria set out below with their weighting:
|1 Criteria related to finished products||50 points|
|2 Criteria related to the mode of production of raw materials and finished products||30 points|
|3 Criteria related to the proper execution of the supply of medical cannabis for experimentation||20 points|
- In the absence of elements or document answering the points on which the ANSM wishes to have details in order to understand and judge the supplier’s offer, the ANSM is able to apply the score of 0.
- Without this constituting an obligation, the ANSM may also ask suppliers in writing to clarify their offer when certain elements are unclear, inconsistent or uncertain.
- At the end of the examination of the files, the ANSM publishes on the Agency’s website the list of suppliers and distributors who are selected to participate in the experiment.