When will the current requirements no longer be adequate for a product to be imported ?

As of first September 2002, all medicinal products currently registered with the Medicines Authority (MA) will require a Provisional Market Authorisation (PMA) to be imported.

   Question - Will products already in stock and imported prior to 1st September 2002 using the current system, be allowed to be placed on the market?

Yes, products already in stock can be sold. The new system will only regulate the importation of products after first September 2002.

   How can an application for a Provisional Market Authorisation (PMA) be made?

Applications for a PMA will be done in two stages:

Stage 1
Submission of the completed questionnaire - Licensing Review of the products on the Maltese Market, (Ref.No.MA002/01).

Stage 2
Submission of the relevant documentation.

   What is the closing date for stage 1 of the application?

The questionnaire must reach the MA by not later than 31st January 2002. Questionnaires completed before the above mentioned date should be handed in as soon as possible.

   Does a questionnaire have to be filled in for each product?

Yes, since each medicinal product has its own particular characteristics, the questionnaire must be filled in for each product; for which a PMA is requested.

   Are products with different dosage forms and or medicinal strengths considered as different products?

Yes. A questionnaire has to be filled in for each dosage form and or medicinal strength of product.

   What determines the type of application to be filed?

The types of application are described in Annex 1 of the questionnaire (Ref.No.MA002/01).

   Who should fill in the questionnaire?

The questionnaire should be filled and signed by the prospective Market Authorisation Holder (MAH) i.e. the applicant. The applicant will thence shoulder all the responsibilities of a MAH.

   Who is the Marketing Authorisation Holder?

The Marketing Authorisation Holder (MAH) is the person who holds the authorisation to place a medicinal product on the market and is responsible for that medicinal product.

   Who should the questionnaire be discussed with?

Local importers are strongly advised to liaise with their principals abroad to discuss the questionnaire with them.

   How and when should the questionnaire be submitted?

The completed questionnaire should be placed in a sealed envelope marked "MARKET AUTHORISATION PROJECT" and should reach the MA by not later than 31st January 2002. Should any questionnaire be completed prior to the mentioned date, please submit immediately.

   Which documents have to be submitted in stage 2 of the application if a CPP from a country listed in Annex 3 is available?

A Provisional Marketing Authorisation (PMA), for products already licenced in any country listed in Annex 3 of Questionnaire, will be granted upon submission of:

(a) a filled in application form for PMA
(b) a valid CPP (from a country listed in Annex 3)
(c) a summary of product characteristics (SPC) approved by the regulatory body issuing the CPP
(d) a copy of the official package insert
(e) the packaging of the product.

   If a valid CPP, issued from a country mentioned in Annex 3 of the questionnaire, is already available at the MRU does it have to be submitted again?

No, if the CPP is still valid, the submission of another CPP is not required.

   Which documents have to be submitted in order to obtain a provisional market authorisation for products which are licenced in countries other than those listed in Annex 3 of the questionnaire?

For products not licensed in a country listed in Annex 3, a PMA will be granted upon submission of an EU-type dossier (see annex 1 of previously mentioned questionnaire).

   Is there any other way besides the submission of an EU-type Dossier for obtaining a PMA for a product licenced in another country than those listed in Annex 3 of the previously mentioned questionnaire?

Yes re-routing of the product is possible. This is done by submitting a new CPP from one of the countries listed in Annex 3 of the questionnaire together with the other documents listed in the question answered above may be submitted. The CPP submitted must relate to the product being placed on the market, this includes the site where it is manufactured and Product Licence (PL) number. may thus be necessary.

   When should the relevant documentation for the second stage have to be submitted?

Once the completed questionnaire has been validated by MA, applicants will be informed of the fees structure. It is envisaged that this will take place in March/April 2002. If the applicant decides to obtain a PMA for a particular product, the applicant should then submit the application form for PMA accompanied by the appropriate fee. The applicants will be contacted at a later stage to submit the relevant documentation.

   Will the total fees have to be paid on submission of the relevant documentation?

The fee structure and method of payment will be determined by March/April 2002.

   Will the government offer financial help by subsidising fees?

The direction given by the government to date is that the costs for the MA to be granted are to be shouldered by the applicant.

   Why is it important for the application to be made by the stipulated date?

The completed questionnaires will enable the MA to establish the projected workload on which basis the fee structure will be composed.

   What will be the impact on the local market?

A preliminary study has already been carried out by KPMG (entitled - Compliance with the Acquis Communautaire with regard to the registration of medicinal products, published - 7th July 2000) . A clearer definition of the impact on the local market can only be obtained once the completed questionnaires are analysed.

   If Malta where to join the EU what options would there be to obtain a market authorisation for a product coming from a non-EU (third) country?

This can be done in three of the following ways:

(a) Submission of an EU type dossier (and payment of fees) to the Maltese Authority (national application). This would provide a market authorisation for Malta only.

(b) If the same product is already marketed in another EU country, an application (and payment of fees) could be made to the authority of that country. The authority in that country (which will be known as the reference member state) will then process the application by what is known as a 'mutual recognition' procedure. In this procedure the market authorisation for the product, which enables the product to be sold in that particular country will be extended to cover the Maltese market (Malta would then be known as the concerned member state).

(c) In addition, an application could be made to the European Agency (EMEA). This is a centralised procedure whereby a Market Authorisation is granted in all EU member states simultaneously. This is adopted for biotechnology products and innovatory products including human blood or plasma products.

   When a market authorisation is granted for a product, will it be possible to parallel import the same product?

Any product which is essentially similar to a product which has been granted a MA is eligible for parallel import by a licensed pharmaceutical wholesale dealer. The system and regulation structure will be the subject of a future seminar.

   What will happen when a tender for the supply of a product to the GPS has been awarded for the next future years?

This subject is still being discussed between the Health Division and the Director of Contracts.

   Will the GPS be allowed to import a product which is out of stock without applying for a MA?

The GPS will be subject to the same regulations as other wholesale dealers

   Will the GPS be licensed in the same way as the private sector?

Yes. The same regulations will apply both to the public and private sectors.

   What language should the dossier be in?

The dossier should be submitted in english. The translation, completeness and correctness of the data submitted are the responibility of the applicant.

   Is there any fee charged for not importing all the products for which a questionnaire has been submitted?

No

   Products like multivitamins which are classified in the exporting country as food supplements, are not imported with a CPP (but with a certificate covering foods). In Malta these products have not yet been classified as medicines or food supplements but as OTC or POM , Pharmacy only by the point of sale committee. As a result will the importers of such products need to fill in the questionnaire in order to obtain a PMA for importation purposes?

At the moment the borderline committee has not been set up and therefore we accept the classification given by the exporting country. In those cases where the product is currently being imported with a foods certificate the questionnaire need not be filled in at the moment and the certificates covering food supplements can be used in order to import these products.

This subject will also be discussed in a future seminar.

   Should the outer pack of products, imported from countries listed in annex 3 of the questionnaire, contain the product licence number and the marketing authorisation holder in order to be granted a PMA?

At the moment this is not a requirement in order to grant a PMA.

   What about influenza vaccines, does a new dossier have to be submitted for every different strain each year?

Depending on the change in information in the dossier a renewal of MA will be processed within the appropriate time frames.

   Will the present system of placing medicnal products on the local market change if Malta does not join the EU?

The new Medicines Act, which will regulate the new system of placing medicinal products on the local market, will come into force irrespectively of whether Malta joins the EU or not.

   Does a questionnaire need to be filled for different pack sizes of the same preparation?

No. Only one questionnaire needs to be filled. The pack size should be specified on the questionnaire.

   Should the SPC be stamped by the health authority of the exporting country?

The SPC submitted has to be the one which is approved by the agency of the country where the product is licenced. It need not be signed by the health authority. The applicant of the PMA is responsible to ensure that the SPC submitted is the one approved by the agency.

   Can you please define abridged applications, and the category of abridged application in which a generic would fall.

Complex abridged applications are unlikely to be used by generic manufacturers. A scenario in which a generic application might become a complex abridged application is if the active supplier does not have an assessed drug master file; in which case the so active ingredient component would also have to be assessed as well as the finished product, making the process more complex.

Standard abridged is the usual route for generic applications. It is an application claiming essential similarity with the innovator, not requiring clinical trials but having to prove bioequivalence for the safety/efficacy and using the basic summary of product characteristics of the originator. This application can be used where there is extensive knowledge of the active ingredient, and the safety/efficacy of the product proved with bibliographic evidence (e.g. a new aspirin or paracetamol tablet licence application might fall into this category).

Simple abridged would be applications where the innovator gives the Licensing Authority free access to the data on its product in order to assess the new application. This would be a sort of "Piggy-Back" application.

A more detialed description of the application types is given Annex 1 of the questionnaire which is also available online in the publications section.