By: Graciela Gutiérrez/Paralegal El Salvador
In the sanitary registry of pharmaceutical products, medical, cosmetic and hygienic devices there is the figure of the manufacturer who is in charge of all the operations involved in the purchase of materials and products, production, conditioning, quality control, approval, storage, distribution of the finished product and related controls
With regards to business name of a company is defined as the name or official name of a company, that is, it is the way of naming the legal person and that allows it to be unequivocally identified. This name is used for formal, legal and administrative uses and does not have to coincide with its commercial name or with the brands it sells.
Having said this, we can consider that when it comes to a change of name of the company of the Manufacturer of a product, we will be making a Change of Company Name of the Manufacturer and the following information must be presented:
- Post Legal Changes Form – Registration of Pharmaceutical Products, Medical, Cosmetic and Hygienic Devices, indicating “Change of business name”, whether of the owner, manufacturer or conditioner;
- Legal document proving the change, duly legalized.
At this point it is important to clarify that the ideal document to present is the document that declares the change that has occurred in the name of the company, and these can be: "Modification of the articles of incorporation of the company", "Modification of the constitutive act of the company”, “Certificate of incorporation on name change”, “Deed of company transformation”, among others, and this will depend on the country where the name change occurred, since each country has specific names for the issuance of your documents.
- New packaging material or label.
It is important to clarify that when the Manufacturer company sells its facilities to another company, we are not facing a change of Company Name or Change of name, in this case we will present a Change of Manufacturer, since it is a different company that will be in charge of manufacturing of the product, although it is true that the facilities remain the same, the company that owns the facilities changed, so we cannot say that we are facing a name change, since the previous manufacturing company continues to exist with the same name, and the new owner of the facilities is a company that already existed previously.
For a Change of manufacturer, the documentation to present is the following:
- Complete form signed and sealed by the Responsible Professional, owner and/or Representative, Legal Representative.
- Certificate of Pharmaceutical Product type WHO, according to numerals 4.7 and 7.3. RTCA 11.03.59:11 (when applicable). o Certificate of Free Sale, in accordance with numerals 7.3.1 RTCA 11.03.59:11 (When applicable)
- Certificate of Good Manufacturing Practices of the new manufacturer according to numeral 7.3.2. RTCA 11.03.59:11
- New original labels of the primary, secondary container/packaging or their projects according to current RTCA of Labeling of Pharmaceutical Products for Human use.
- Report of the Stability Study in accordance with the RTCA of Stability Studies of medicines for Human Use in force.
- Updated and validated Analytical Methodology according to numeral 7.7. RTCA 11.03.59:11
- Contract with the new manufacturer in accordance with the provisions of section 7.4, registration requirements.
- Qualitative-quantitative formula certification (applies if it is not included in an official document issued by the regulatory unit of origin).
Adicional You must declare that there is no product in existence, otherwise process Packaging Exhaustion (Medical Area Form).
Important to take into account the following:
- A Manufacturing contract will not be presented when the Owner and manufacturer are subsidiaries or affiliates of each other, in this case a letter issued by the owner will be presented mentioning this and must comply with the corresponding legal regulations.
- When the manufacturer has sold the facilities to another company, a letter can be submitted mentioning that the stability studies and analytical methodology will not be submitted since they are still the same facilities and have not undergone changes.
If you need advice, you can contact our Life Sciences team, highly trained and specialized in the subject; At LatinAlliance we are known for always providing the necessary support to our clients.