ANVISA REGISTRATIONS AND TERRITORIALITY: SOME ANCILLARY CLAUSES WHICH ARE NECESSARY TO DISTRIBUTORSHIP OF MEDICAL DEVICES, MEDICINES, COSMETICS AND OTHERS PRODUCTS UNDER ANVISA REGULATION
Although the distributorship agreement is regulated in Brazil by Brazilian Civil Code and other special laws, regulatory issues need to be considered to distributorship of medical devices, medicines, cosmetics and others products under ANVISA rules.
It is important to clarify, mainly to foreign manufacturers, in case of international distributorship agreements, the first step is to evaluate the situation of Brazilian distributor, a kind of due diligence, since distributor shall keep sanitary licenses and authorizations as requested by local laws to import and commercialize such medical devices, medicines or any other products which are under ANVISA regulation.
Another point which generates many doubts, specially to foreign manufacturers, is related to the exclusivity of territory. Many manufacturers has the idea that the registration holder has the right of exclusivity in commercializing the medical devices or medicines they hold the registration at ANVISA, what means that only the registration holder could buy and resell the products in Brazil.
Yes, it is correct to state that only the registration holder can commercialize in Brazil, however, the exclusivity of commercialization has no relation with the maintenance of registration by the distributor (registration holder).
This is because (i) as per Resolution RDC 81/2008 - ANVISA, it is allowed to registration holder to authorize the import and distribution by a third party, and this third party shall also keep sanitary licenses and authorizations as requested by local regulation to the activities of import and distribute medical devices, medicines or any other product under ANVISA regulation, and, (ii) it is possible that the same product has more than one registration at ANVISA, which means that the same product can be registered by more than one company (registration holder).
Hence the importance of rules related to use of such registrations after the termination of a distributorship agreement, since there are many agreements that do not mention any rule for this issue, especially when the termination is due to distributor failure in accomplish any rule of the agreement or law or, for example, when there is no regulation about the situation of registration in case of distributor bankruptcy or if the registration is an asset of distributor.
Whether the transference of registrations property were allowed by ANVISA regulation, that is still under public consultation at ANVISA (Consulta PÃºblica nÂº 4/2015) for cases not provided for by Resolution RDC n. 22/2010 - ANVISA, distributor and manufacturer could adjust the assignment of registration property to a third party or manufacturer representative in Brazil in the termination of the distributorship agreement. For a while, and even with the new regulation regarding the transference approved by ANVISA in the future, such rule must be clear in the agreement, since there are high investments done by distributor or manufacturer to obtain the registrations at ANVISA.
We just like to point out that registration and territoriality are related clauses, however independent and shall be considered in the distributorship agreements, mainly in case of termination of distributorship agreement.