Requirements for import of active substances (API) - questions and answers
Will the Danish Medicines Agency (DKMA) host a meeting for the industry on import of active substances?
No. Instead of organising another meeting for the industry, we will post information on the DKMA website to ensure we provide the same information to everyone in the industry. But if you have more specific questions, please contact our unit Company Authorisations and Distribution at – email@example.com
Where can I find more information about requirements for import of active substances?
We provide information on our website, but the European Commission has also published a questions and answers document with relevant information:
Do the rules on the written confirmation also apply to active substances for veterinary medicines?
No. The rules apply only to active substances for human medicines.
Do the rules on the written confirmation also apply to active substances of investigational medicinal products?
Active substances to be used in investigational medicinal products are subject to the rules if the investigational medicinal product has a marketing authorisation. Active substances to be used in investigational medicinal products are not subject to the rules if the investigational medicinal product does not have a marketing authorisation.
What if at the time of import it is unknown whether or not the active substance is to be used in human medicines?
If there is no written confirmation, the active substance must not be used in human medicines.
Do the rules on the written confirmation also apply to active substances intended for use in medicines to be exported exclusively to third countries?
Where can I find the list of countries where a written confirmation is not required?
The list is available at the website of the European Commission: http://ec.europa.eu/health/human-use/quality/index_en.htm
Is it possible after 2 July 2013 to release finished products with active substances imported from a third country before 2 July 2013 which then were not accompanied by a written confirmation?
The date of import of the active substance is decisive. If the active substance was imported into the EU/EEA before 2 July 2013, no written confirmation is required. This means that manufactured medicinal products containing active substances imported before this date can be released.
Is it possible to order an active substance and possibly also receive it before a written confirmation is available if the consignment is quarantined on arrival and not released until the written confirmation is obtained?
It would be natural if the written confirmation from a third country is obtained before import into the EU. If, for some reason or other, the company has not received the written confirmation before receiving the active substance, the active substance must be quarantined and may not be used until the written confirmation is obtained.
Will the DKMA check the basis on which third countries issue written confirmations?
There will be no routine control of written confirmations. However, the EU authorities will maintain their risk-based approach and will randomly carry out inspections of specific companies. The consequences of subsequent GMP non-compliance by an active substance manufacturer will be the same as today, i.e. potential withdrawal of the concerned medicinal products.
If the need arises to waive the requirement for a written confirmation and the active substance is imported in one EU country and subsequently in other EU countries, will all authorities of the EU countries then have to waive the requirement?
The national competent authorities may in special circumstances waive the need for a written requirement to ensure the availability of medicinal products, provided that a GMP certificate exists. It is therefore up to each Member State where the manufacture of medicinal product containing the active substance takes place to address the question of potentially waiving the requirement for a written confirmation.
Where and how will it be checked if an active substance is either covered by a written confirmation issued by the authorities in the third country where it is manufactured or comes from a third country on the Commission's list of countries assessed to have a regulatory system corresponding to EU standards?
Manufacturers of medicinal products are obliged to ensure and document compliance with the rules on import of active substances from third countries. Companies that import active substances for redistribution must also ensure and document compliance with the rules on import of active substances from third countries, and must always do so if the company knows that the active substance is to be used in registered medicinal products for human use.
The DKMA will monitor compliance with the rules in relation to finished product manufacturers as well as companies importing active substances.
SKAT, the Danish customs authorities, will not check whether the import rules have been observed in connection with the actual import, but they will be able to ensure that the importer has either an authorisation or is registered.
Must a company apply for a waiver from the written confirmation before the active substance is dispatched from the third country?
If a written confirmation cannot be obtained, it would be natural for the company to seek a waiver from the requirement by applying to the DKMA before dispatch in the third country. The requirement can, however, be waived later, but never later than before the active substance is used.
Will inspections of active substance manufacturers carried out by non-EU countries be accepted as a basis to waive the requirement of a written confirmation?
The requirement can be waived only when the manufacturing site of the active substance has been inspected by an EU authority and is covered by a valid GMP certificate.
Will companies receive a written reply when they apply to the DKMA for a waiver from the requirement for a written confirmation?
If the DKMA waives the requirement for a written confirmation, will it only apply to one import or will it be valid for a period?
A waiver of the requirement for a written confirmation will apply for a limited period of time, typically corresponding to the validity of the GMP certificate.
Will the authorities' waivers of the requirement from the written confirmation be published on the Commission's or other websites
The DKMA has no plans of publishing its decisions regarding waivers of the requirement for a written confirmation. These waivers are granted on a case-by-case basis, and not in respect of imports of a given active substance from a given site in general.
What significance does it have for Danish companies that the directive will not be implemented in all EU countries on 2 July 2013?
It is not unusual that directives are implemented at different stages across the EU. It is the responsibility of the Commission to follow up on potential failure and delays in implementing the directive in the individual countries.
The directive on falsified medicinal products regarding import of active substances from third countries has been implemented in Denmark and is effective from 2 July 2013 as required by the directive. After that date, the rules must be complied with by Danish companies. It is the responsibility of the finished-product manufacturer to ensure that the active substances they use for manufacturing comply with the rules.
If a company based in Denmark or another EU country wants to ensure that an active substance can be used in a registered medicinal product for human use in all EU countries, the rules on import from third countries must be complied with.