Importing Active Ingredients from Third Countries after the Accession of Croatia to the EU
Considering the accession of the Republic of Croatia into the European Union, HALMED wishes to inform drug manufacturers and manufacturers, importers and wholesale distributors of active ingredients about the expected requirements regarding importing active ingredients.
Each shipment of an active ingredient coming from a third-country must have a written confirmation enclosed by the competent body of the third-country in which active ingredient production is situated. This written confirmation certifies that:
- the active ingredient was produced at a location where the demands of good production practice, in accordance with those the European Union prescribes, are being met,
- the production location is under regular, rigorous and transparent supervision regarding good production practice
- the exporting country is obligated to notify the European Union immediately in cases of supervision discrepancies.
The shipments do not have to come with a written confirmation enclosed if the exporting country belongs on the list of countries approved by the European Commission (the list is in the following section). In order to achieve placement on this list, the country must submit an application and follow an evaluation process that includes a survey of legislation and a visit by a qualified person responsible for drugs from some EU constituent country.
Exceptionally and where necessary to ensure the availability of medicinal products, when a plant manufacturing an active substance for export has been inspected by a compentent Authority of Member State and was found to comply with the principles and guidelines of good manufacturing practice prescribed for manufacturing of active substances, the required written confirmation may be waived for a period not exceeding the validity of the certificate of Good Manufacturing Practice.
The most recently published information expresses the status of third-countries that export the greatest number of active ingredients into the EU as follows:
- Switzerland - on the list
- Australia - on the list
- Japan - the evaluation procedure and inclusion on the list are currently underway
- USA - the evaluation procedure and inclusion on the list are currently underway
- Brazil - the evaluation procedure and inclusion on the list are currently underway, a visit from a qualified person responsible for medicinal products of a EU constituent country is planned for Autumn 2013
- Israel - the application for inclusion on the list has been submitted, but has not been approved so far (the currently valid legislation only deals with active ingredients produced for Israel drug production, not exportation)
- Singapore - the application for inclusion on the list has been submitted, but has not been approved so far, Singapore will issue written confirmation (according to currently valid legislation, the confirmation of good production practice is not mandatory)
- India - the competent body will issue written confirmation
- Canada - the competent body will issue written confirmation
- China - the competent body will issue written confirmation from May 2013 for all production facilities under its supervision (a list of these facilities is available here).
- Korea - issues written confirmation
- Mexico - will issue written confirmation and an application for inclusion on the list has been announced
- Taiwan - the competent body will issue written confirmation
- Thailand - the competent body intends to issue written confirmation
- Malaysia - an application for the inclusion on the list has been announced, but due to the fact that the application has not yet been received, the European Commission has requested the issuance of written confirmation
- Argentina - an application for the inclusion on the list has been announced, but due to the fact that the application has not been received yet, the European Commission has requested the issuance of written confirmation
Considering the above, all drug manufacturers in the Republic of Croatia are urged to contact their suppliers and producers of active ingredients in third-countries and confirm the availability of a written confirmation. If at this point there is information that a certain active ingredient will be prevented from shipping with a written confirmation, the manufacturers are also urged to deliver such information, as per the table available here, to HALMED, to the e-mail address firstname.lastname@example.org. HALMED will conduct further assessments on the basis of the delivered information and, as needed, plan the supervision of active ingredient producers in the third-country.