On June 2nd, 2021, the resolution from the AEMPS to the Regulation (EU) No. 528/2012, which attributes the status of medicine for human use to “antiseptics intended for the preoperative surgical field and for disinfection of the injection site”, came out.
Recently, the AEMPS has shared new documents that provide additional information of interest for the transition from biocidal product to medicine.
Here are some key points to be taken into account:
- There will be a 95% tax reduction during the transition period, until June 1st, 2022.
- Remnants of biocide products may exist on the market with this use only until stocks are finalized.
- It is possible to keep the biocidal product on the market if the indications for disinfection prior to surgical treatment or for use in an injection site are deleted before 1 June, 2022.
- It is possible to extend the indications, (e.g., wounds and mucous membranes) according to what is authorized in the reference medicine.
APPLICATION FOR AUTHORIZATION AS A PHARMACEUTICAL LABORATORY
It is recommended to request the opening of a pharmaceutical laboratory manufacturer (or importer) as soon as possible, and be prepared for the GMP inspection, since only once this authorization has been granted, the application for authorization of the drug can be submitted.
- It is possible to outsource the manufacture of the drug to a third party (through a technical agreement) until the own facilities comply with the GMP.
- The manufacturing plant must have a Technical Director and an alternate They must also have previous experience in a pharmaceutical laboratory that manufactures medicines.
APPLICATION FOR MARKETING AUTHORISATION AS A MEDICINAL PRODUCT
- It is recommended to apply on a hybrid legal basis if there is a reference medicine. If there is no reference medicinal product, it is recommended to submit the application for well-established use.
- Until June 1st, 2022, the national procedure will be the means of registering the files.
- To ensure efficacy and safety, medicinal products must comply with the provisions of the European Pharmacopoeia to demonstrate in vitro bactericidal/fungicidal/levuricide efficacy (Ph Eur 5.1.11.). Alcohols are considered special active ingredients.
- If the laboratory already has a register of medicinal product with the same formulation, an extension of the indication by means of a variation (type II. C.I.6. a) is to be requested.
- The use of the same brand name for a preoperative surgical antiseptic medicinal product or injection site and a biocidal product with the same composition intended for use on healthy skin shall be assessed on a case-by-case basis.
The new documents shared by the AEMPS provide additional information and FAQs of great interest for the transition to medicine and from Asphalion we can offer our support at all stages ensuring compliance with the deadlines established by the AEMPS.
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