News Related to Importing Active Substances from Third Countries after the Accession of Croatia to the EU (10 August 2015) - NEW
In relation to the accession of the Republic of Croatia to the European Union, HALMED wishes to inform manufacturers of medicinal products and manufacturers, importers and wholesale distributors of active substances about the changes in the status of third countries regarding the expected requirements for the import of active substances into the EU.
Similarly as before, each shipment of an active substance arriving from a third country that is not on the list of countries approved by the European Commission ("List" hereinafter) must have a written confirmation issued by the national competent authority responsible for medicines of the third country in which the active substance is produced. This written confirmation certifies that:
- The active substance has been manufactured on a site where the requirements of good manufacturing practice are met, and which conform to the standards applied in the European Union,
- The manufacturing site is under regular, rigorous and transparent inspection with respect to its compliance with the principles of good manufacturing practice,
- In case of deviation from such principles, established during inspection, the exporting country is required to notify the European Union immediately.
In order to be included on the List, the exporting country needs to submit an application and undergo an evaluation procedure that entails an assessment of its legislation and a visit from a representative of a national competent authority for medicines of an EU Member State.
Exceptionally, and where necessary to ensure the availability of medicinal products, the imported active substance does not need to have a written confirmation in the period not exceeding the validity of the Good Manufacturing Practice Certificate if its manufacturing site has been inspected by a representative of a national competent authority for medicines of an EU Member State and was found to comply with the requirements of good manufacturing practice applied in the EU.
According to the most recent information published by the European Commission, the status of third countries that export the greatest number of active substances into the EU is as follows:
- Brazil - is on the List since 2 July 2015, and the decision for including it on the List came into force on 22 July 2015
- India - CDSCO, India's national competent authority for medicines, has re-organised its website that contains the written confirmations; in case of difficulties in verifying the confirmations, send an e-mail to halmed@halmed.hr
- Israel - is on the List since 2 July 2015, and the decision for including it on the List came into force on 22 July 2015
- USA - is on the List since 21 June 2013, and the announcement published by the FDA is available here
- Japan - is on the List since 5 June 2013
- Australia - is on the List since 25 April 2013
- Switzerland - is on the List since 23 November 2012
- Argentina - its national competent authority publishes written confirmations (so far it has published 16 confirmations); submission of a request for inclusion on the List has been submitted
- Canada - its national competent authority publishes written confirmations (so far, it has published 13 confirmations and 13 requests encompassing 87 active substances)
- China - its national competent authority publishes written confirmations; in case of difficulties in verifying the confirmations, send an e-mail to halmed@halmed.hr
- Indonesia - its national competent authority has started to publish written confirmations
- Malesia - its national competent authority publishes written confirmations (so far, it has published four confirmations), submission of a request for inclusion on the List has been postponed until further notice
- Mexico - its national competent authority publishes written confirmations (it has published nine confirmations so far)
- New Zealand - a request for inclusion on the List is put on hold
- Singapore - its national competent authority publishes written confirmations (so far, it has published nine confirmations that encompass all the manufacturing sites)
- South Africa - its national competent authority publishes written confirmations
- South Korea - its national competent authority publishes written confirmations (so far, it has published 54 confirmations encompassing 105 active ingredients), a request for inclusion on the List has been submitted and the evaluation of conformity is underway
- Taiwan - its national competent authority publishes written confirmations (so far, it has published 76 confirmations that encompass 18 manufacturing sites and 138 active ingredients altogether); submission of a request for inclusion on the List is intended
- Thailand - its national competent authority intends to publish a written confirmation
- Turkey - its national competent authority publishes written confirmations (so far, it has published 12 confirmations encompassing 212 active substances)
- Ukraine - its national competent authority publishes written confirmations.
In case that a written confirmation is not available for a certain active substance, manufacturers are asked to act in accordance with paragraph 7, subparagraph 4 and 5 of the Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesalers of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (Official Gazette No. 83/13)
Additional information is available on the web page of the European Commission, here, and in the "Questions and Answers" document.
