Specialist pharmaceutical consulting in Spain

The AEMPS (Spanish Agency of Medicines and Medical Devices) is the agency that regulates all procedures related to the authorisation, marketing, and control of pharmaceutical products. Therefore, cosmetics and medical devices are regulated by the Spanish Agency of Medicines. In the case of medical devices, importing and manufacturing actors must submit an application for an authorisation licence to the AEMPS in order to carry out manufacturing, importation, grouping, or sterilisation activities. Until a response is obtained from this regulatory body, medical device actors may not legally carry out their activity. In the case of cosmetic products, actors must submit a licence application that does not require prior evaluation by the AEMPS to be issued, unlike medical devices; however, the AEMPS may subsequently request additional documentation or carry out control activities on the company conducting activities with cosmetics.

To obtain a medical device licence, it is necessary to submit the prior authorisation licence application for the import/manufacture/grouping/sterilisation of medical devices on the IPS platform available at this link: https://fabricaps.aemps.es/fabricps/faces/login.xhtml. The documentation required to submit the application varies widely: from standard operating procedures to company floor plans, contracts, etc. The time required to obtain the prior medical device licence varies: it can take between 1 and 3 months, as the first response from the AEMPS usually takes one month, but it is normal for them to send a request for additional documentation or for amendments to the content of documentation submitted. They will then issue a licence conditional upon inspection.

Once the AEMPS has issued the prior operating licence for medical device facilities, the activity may be carried out as normal, although always conditional upon inspection; this means that the health authorities may request a visit to the facility and the documentation associated with the activity at any time. They typically review the facility and documentation, workflow, staff training, etc. Once the inspection is approved, the definitive licence is issued. Otherwise, if an unfavourable inspection report is issued, the licence may be revoked. The licence is valid for 5 years from the date the licence conditional upon inspection is issued, regardless of any visit by the health authorities. Once these 5 years have passed, a new medical device health licence application must be submitted again.

With the issuance of this licence, the activity may be carried out with any type of medical device, although it is advisable to specify, at the time of application, which type of product will be handled, especially in the application for a medical device manufacturing licence.

Yes. In the case of IMPORTATION, a technical responsible person is required with a minimum dedication of 10 hours per week; in the case of MANUFACTURE, a dedication of 20 hours per week is required; in the case of GROUPING, 20 hours per week; and in the case of STERILISATION, the dedication must be full-time (40 hours per week).

No, the role of technical responsible person is incompatible with other healthcare activities that conflict with the interests of the companies.