AIFA has recently published the updated procedures to be followed for the initial submission of an Active Substance Master File (ASMF) and any subsequent updates.

An ASMF, formerly known as European Drug Master File (EDMF), is a set of documents that contains all information on the manufacturing process, characterization and physicochemical properties, quality control procedures and requirements, and stability data of the active substance.

The purpose of an ASMF is either to protect the manufacturer's confidential intellectual property or to provide health authorities (HA) with complete information on the active ingredient contained in a medicinal product for which a Marketing Authorization Application (MAA) is submitted.

From now on, the electronic Common Technical Document (eCTD) must be used to organise the content of the ASMF into modules, sections and documents. The submission of the dossier and subsequent updates must be performed through the Common European Submission Portal (CESP).

Regulatory Pharma Net (RPN) can fully manage the development of the CTD and eCTD dossier for all regulatory procedures and can support companies also in the preparation and submission of the eCTD ASMF dossier.

Please feel free to contact us at info@regulatorypharmanet.com

In September 2020, Legislative Decree No. 116 of 3 September 2020 was published in the Italian Official Journal (IOJ), in relation to the labelling of packaging, which transposes EU Directive 851/2018 on waste and EU Directive 852/2018 on packaging and packaging waste and amended Article 219(5) of Legislative Decree 152/2006.

Effective from January 1st, 2023, environmental labelling decree obliges cosmetics manufacturers, packaging material suppliers, processors and importers of empty packaging and packaging materials that each bottle, jar and container be labelled with its material, so as to facilitate its disposal by the consumer.

In particular, it is mandatory to state on the label:

• the alphanumeric coding identifying the material (as per Decision 129/97/EC) even for all manually separable components of the packaging system;
• information to support the consumer in the correct collection of packaging (e.g. "Separate collection, Family of material, Check your municipality's regulations").

On a voluntary basis, it is advisable to include additional information to increase the quality of the separate collection (e.g.: empty the packaging before placing it in the collection).

The decree does not specify which graphic style to use; it recommends that the packaging be appropriately labelled, so it leaves freedom of choice as to the graphic style, form, font height and colours of the environmental labelling. Obviously, it is assumed that, in addition to being clear, not misleading and easily understood by any consumer, the labelling must be clearly legible.

On this basis, the use of digital tools is allowed (e.g. Apps, QR codes, websites), consistent with the process of technological innovation and simplification, a fundamental aspect envisaged within the Italian National Plan for Recovery and Resilience Plan.

Regulatory Pharma Net (RPN) is available to provide your company with any updates on the cosmetics regulatory framework and to assist on all regulatory needs.

Feel free to contact us at info@regulatorypharmanet.com

The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a product MAH to support the registration process of a pharmaceutical product of another regulatory authority in a different country.

The CPP confirms:

• the regulatory approval was based on a full evaluation of the product’s quality, safety and efficacy;
• the product is manufactured under good manufacturing practices (GMP); and/or
• the registration and marketing status of the product in the certifying country

Therefore, the CPP is one of the important documents that a MAH needs to submit while entering the Extra – EU market. A CPP not only ensures approval for the product but also guarantees fast market entry.

When a company wishes to submit a CPP application to AIFA, it is crucial to know whether or not the medicinal product in question has been assigned the Italian MA numbers (AIC numbers), since the approval and submission process is different.

Once the submission and evaluation by AIFA has been completed, the CPP is issued in the form of a digitally signed documentation and then should be legalized.

Our Regulatory Pharma net team can support your company in all regulatory steps (document preparation, submission, contact with the regulatory authority and legalization process at embassies).