As of May 1st, the DNM issued a communication regarding the non-requirement of the registration of a manufacturing contract in the following cases:
1. When the legal relationship between the holder of the sanitary registration and the manufacturer it’s stated in the Certificate of Pharmaceutical Product type WHO (World Health Organization)
2. When they are affiliated or subsidiary companies.
3. When the holder of the sanitary registration is the owner of the laboratory where the product will be manufactured.
In substitution to this new provision, the following must be submitted:
1. Certificate of Pharmaceutical Product type WHO that declares the holder and manufacturer of the product, as it’s registered in the country of origin.
2. For cases in which the holder and manufacturer are related under the figure of an affiliate or subsidiary, a letter or certificate issued by the holder must be submitted in which the relationship between them is established, or a quality agreement in which the compliance with the minimum safety conditions is determined.
For foreign laboratories, the registration of manufacturing contracts is no longer required, however, when the manufacturer is a third party and is not under the figure of an affiliate or subsidiary, it is necessary to submit the manufacturing contract in the procedures that require it according to RTCA 11.03.59:11, and this must have at least the requirements mentioned in this regulation in paragraph 7.4, being these the following:
a) Signed by the holder and the manufacturer jointly or separately.
b) Commitment to comply with Good Manufacturing Practices.
c) Establish the production conditions, analysis when applicable, or any other technical management related to these.
d) Must describe the handling of raw materials, packaging material, bulk material, and finished product and in case they are rejected.
e) Allow the client to enter the contractor’s facilities for audits.
f) Allow the contractor’s (contracted) entry to the contractor’s facilities.
g) List each one of the products or analysis services object of the contract.
For such purposes, the procedures involved in this new provision are as follows:
– New Registration
– Change of Holder
– Change of Manufacturer
– Alternate Manufacturer
– Change of Conditioner
Currently, the authority is constantly changing, so it is advisable to have the advice of a highly trained and specialized team on the subject; in LatinAlliance we are known for always providing the necessary support to our customers.