Pharmaceutical Company Creation and Marketing Authorization

Extract

[...] I have taken into account your requests and please find, attached, the answers to your questions. 1. The formal creation of a pharmaceutical sales company In as much as you wish to create a company whose social object is clearly to market drugs and pharmaceutical products, I advise you to follow three key steps in the success of your project. The first step is to obtain an authorization, from the competent authority, for the creation of the said company. In accordance with Article L 5121-3 of the Public Health Code, the explicit opinion of the Director General of the National Agency for the Safety of Medicines and Health Products (ANSM) is required in the context of the creation of such a company. [...]

[...] The procedural branch of mutual recognition at the European level is added to the national procedure mentioned above. It involves two states: the state of origin of the marketing authorization, or the reference state (in your case, Romania) and the state of application of the said authorization in the context of the commercialization of the aforementioned pharmaceutical products (or the recipient state). The centralized procedure branch is particularly useful to you, as it is a matter of a prior general and upstream marketing authorization for particularly innovative products - such a authorization is issued by the European Commission and its validity extends to all member states of the Union, for a period of ten years. [...]

[...] To summarize, I recommend that you first focus on the formal authorization for the creation of a commercial pharmaceutical products company under the auspices of the ANSM; secondly, on the authorization for the French market launch of the products within the framework of a transfer procedure; and thirdly, on the idea of general awareness based on the public interest and public health rather than a strict promotion of pharmaceutical products with a purely commercial objective. Please accept, Madam, my sincere greetings. X. [...]

[...] The pharmacist designated as responsible will be required to assume the duties of social representative in accordance with Article R 5124-36 of the Public Health Code. Finally, depending on the establishment created by the applicant company, not only must the latter obtain, for each of its establishments, an authorization constituted in accordance with Article R 5124-7 of the Public Health Code, but also designate a responsible pharmacist in the context of the management of the establishments opened by the concerned company. [...]

[...] First, in a restrictive manner, the French framework develops a national procedure in which the marketing authorization is only valid for the French market. This restrictive vision ignores the underlying aspects of such commercialization within the framework of the European market and does not directly concern you regarding the question of the Romanian company. Structurally, it is indeed the European level, at three levels, that must be considered at the legal application perimeter of the marketing authorization of medicinal products and pharmaceutical products. [...]