This update seeks to clarify and modernize procedures related to the import and export families pharmacists, despite the absence of significant legislative changes in the last decade.
Circular 1/2025 details the steps to request the AEMPS the import and export authorizations of medicines, as well as the requirements for the notification of exports. In addition, it establishes the procedure for the authorization of manufacturing of medicines not registered in Spain and those under investigation for clinical trials not authorized in the country, whether their destination is the European Union (EU) as third countries.
The document also addresses the importation of active ingredients for the manufacture of medicines for human and veterinary use, as well as the import and export of samples of medicines and active ingredients not intended for human or animal use. Another relevant point is the procedure for the export of blood-derived medicines for human use to the intra-community market and the issuance of pharmaceutical product and free-sale certificates.
Key Updates and Clarifications
The update introduces several significant changes to simplify and streamline processes:
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Definition of registered medicine: A clear criterion is established to facilitate the procedure applicable to each type of medication.
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Roles of pharmaceutical entities: It clarifies which entities can carry out each activity and which are authorized to submit applications or communications to the AEMPS.
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Detailed documentation: The documents required for applications for authorization to import, manufacture, and export medicines not registered in Spain or for unauthorized clinical trials are specified, including export certificates to third countries.
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Extension of validity of manufacturing authorizations: Manufacturing authorizations for unregistered medicines destined for third countries have their validity extended from 2 to 3 years.
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Simplification for the EEA: For the European Economic Area (EEA), only one authorization will now be required for shipments to all member countries.
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Notification of entry for export: The procedure for notifying the entry into Spain of medicinal products for human use from other Member States, intended for export by wholesalers, is being incorporated.
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Humanitarian donations: The procedure for authorizing the export of medicines as humanitarian donations is included.
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First aid kits and travelers: Requirements for the procurement of medicines for first-aid kits on ships, yachts, or aircraft are defined, and requirements for medicines intended for the treatment of travelers are clarified.
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Active principles: Requirements for returns, imports, and exports of samples not intended for human or animal use, and the issuance of free sale certificates for active ingredients are addressed.
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Digitization: Certain appendices have been eliminated, as the information is now collected through forms in the AEMPS's specific applications.
This update demonstrates the AEMPS's commitment to transparency and efficiency in foreign trade of medicines, adapting to the needs of the sector without requiring profound legislative changes.
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