The regulatory authority that is in charge of the sanitary registries of pharmaceutical products, as well as the subsequent changes to their registration, is the National Directorate of Medicines, which is regulated by the Medicines Law, General Regulations of the Medicines Law, Regulations Central American Technician (RTCA 11.03.59:11), the different guides of the units of the National Directorate of Medicines, as well as the different laws and related agreements.
In order to register a pharmaceutical product in El Salvador, it is necessary for the pharmaceutical product to have a Registration Holder (the holder is in charge of issuing the powers of attorney to the legal representative or proxy and to the responsible professional to represent him in the country where it will be registered). registered the product) and we can define it as "natural or legal person who owns the product to whom the health license of the medicine is issued".
When the product has complied with the requirements requested by the Salvadoran legislation to obtain the sanitary registration, it can now be freely marketed in the country, however, the validity of the sanitary registration is for five years, and during this time different modifications could arise. which are necessary to notify the regulatory authority, since if the drug is not found as it was registered, at the time of importing or marketing it there may be different inspections and if the information is not as it was registered, the law authorizes them to sanction to the product and to the responsible professional.
One of the subsequent changes that may exist in the health registration of a medicine is the change of Owner, and according to RTCA 11.03.59:11 the requirements to make the change are:
1. Proof of payment.
2. Application signed and sealed by the Agent and Responsible Professional.
3. New original labels of the primary, secondary container/packaging or their projects according to current RTCA of Labeling of Pharmaceutical Products for Human use.
4. Document issued by the Holder or his Legal Representative that declares the change
5. Manufacturing contract with the new owner, in accordance with the provisions of numeral 7.4, sanitary registration requirements
In requirement number 4 mentioned in the RTCA, the ideal documents in El Salvador to present said change are: the Assignment of Ownership or Sale.
If we use an Assignment of Ownership, it must comply with the formalities required by our legislation, that is, that in the Assignment the figures of the assignor and assignee must appear, in addition that we must legitimize the legal capacity with which the Assignor and Assignee act ( that is, the Legal Representatives of the current Owner and the new owner), these people must have sufficient powers to issue said documents, and the notary or authorizing official according to the laws of the country of origin, must attest that they actually have the representation in whose name proceeds and that this representation is legitimate according to the documents that were shown to him, and in the event that the notary or official cannot attest because his powers do not allow it, to legitimize the legal status we would have to have additional documents, such may be the Special power that the Company gives to represent it in said act, this power must be expressed in the power of attorney. In the event that both figures cannot be present at the time of issuing the Assignment of ownership, an acceptance letter must be sent in which the Assignee is accepting ownership of the product, in which the grantor must legitimize.
In case of not complying with the formalities of the Assignment of Ownership, the authority will issue a warning, which must be corrected in the next 10 business days after receiving the notification, and because they are merely legal issues, it would not be possible to comply with the deadline to respond to prevention.
For requirement number 5, in accordance with the provisions of numeral 7.4, of the RTCA, the Manufacturing Contract or, failing that, the extract related to the parties to the manufacturing contract, when applicable, in original or authenticated or certified photocopy of the legalized document. , containing at least the following information:
a) Signed by the owner and the manufacturer jointly or separately.
b) Commitment to comply with Good Manufacturing Practices.
c) Establish the conditions of production, analysis when applicable, or any other technical management related to these.
d) It must describe the handling of raw materials, packaging material, bulk material and finished product and in the event that they are rejected.
e) Allow the entry of the contracting party to the contractor's (contracted) facilities for audits.
f) Allow the entry of the contractor (hired) to the contractor's facilities.
g) List each of the analysis products or services object of the contract.
At this point it is clear that the manufacturing contract will not only be presented when the Manufacturer of the product is the new owner.
Currently, the issue of Assignment of Ownership in El Salvador is very complex, since every day the Legal Unit of the National Directorate of Medicines is being quite strict regarding the legal documents that are presented in the procedures, so it is advisable to have always with the advice of a highly trained and specialized team in the subject; At LatinAlliance we are known for always providing the necessary support to our clients.