By: Graciela Gutiérrez/Paralegal El Salvador
In the sanitary registration of pharmaceutical products, medical devices, cosmetics, and hygienic products, there is the figure of the manufacturer who is in charge of all the operations involved in the purchase of materials and products, production, packaging, quality control, approval, storage, distribution of the finished product and related controls.
The corporate name of a company is defined as the official name or denomination of a company, i.e., it is the way of naming the legal entity and allows it to be unequivocally identified. This name is used for formal, legal, and administrative purposes and does not have to coincide with the commercial name of the company or with the trademarks of its markets.
Having said this, we can consider that when it is 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 submitted:
- Post – Registration of Pharmaceutical Products, Medical Devices, Cosmetics, and Hygienic Products Legal Changes Form, indicating “Change of company name”, either of the holder, manufacturer or conditioner;
- Legal document that accredits the change, duly legalized.
At this point, it is important to clarify that the suitable document to be presented is the one that declares the change in the name of the company, and these can be: “Modification of the corporate charter of the company”, “Modification of the articles of incorporation of the company”, “Certificate of incorporation on change of name”, “Deed of transformation of the company”, among others, and this will depend on the country where the change of name occurred since each country has specific names for the issuance of its documents. - New packaging material or label.
It is important to clarify that when the manufacturing company sells its facilities to another company, we are not facing a change of corporate 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 the product, although the facilities remain the same, the company that owns the facilities changed, so we cannot say that we are facing a change of name, since the previous manufacturing company still exists 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 be submitted is as follows:
- Completed form signed and stamped by the Responsible Professional, owner and/or Attorney-in-Fact, Legal Representative.
- Certificate of Pharmaceutical Product type WHO, according to the numbers 4.7 and 7.3. RTCA 11.03.59:11 (when applicable). o Certificate of Free Sale, in accordance with the numbers 7.3.1 RTCA 11.03.59:11 (when applicable).
- New manufacturer’s Certificate of Good Manufacturing Practices according to 7.3.2. RTCA 11.03.59:11
- New original labels of the primary container/package, secondary container/package, or their projects according to RTCA of Labeling of Pharmaceutical Products for Human Use in force.
- Stability Study Report according to RTCA on Stability Studies of Pharmaceuticals for Human Use in force.
- Analytical Methodology updated and validated according to numeral 7.7. RTCA 11.03.59:11
- Contract with the new manufacturer according to what is established in numeral 7.4, registration requirements.
- Certification of the Quali-quantitative formula (applies if not included in an official document issued by the regulatory unit of origin).
Additional You must declare that there is no existence of the product, otherwise, process Exhaustion of Packaging (Medical Area Form).
It is important to take into account the following:
- Manufacturing contract will not be submitted when the company Holder and manufacturer are subsidiaries or affiliates of each other, in this case, a letter issued by the holder must be submitted mentioning this and must comply with the corresponding passes of law.
- When the manufacturer has sold the facilities to another company, a letter can be submitted stating that the stability studies and analytical methodology will not be submitted since they are still the same facilities and have not undergone any changes.
If you need any advice, you can contact our highly trained and specialized Life Sciences team; at LatinAlliance we are known for always providing the necessary support to our customers.