Health and Cosmetic Products
2021.1.18
In the case of medical products marketed in Spain, do I have to carry out any additional procedures?
Yes, you will need to update the marketing communications made to the AEMPS through the CCPS.
What will happen if the health products are manufactured or distributed by a company based in the United Kingdom?
As from 1 January 2021, any manufacturer or distributor based in the United Kingdom will no longer be considered as an economic agent based in the EU and will therefore be considered as a third country company. This means it will have to meet the specific obligations required of third country companies, which are different to those required of EU-27 companies. Hence, after Brexit, all Spanish companies that acquire health products in the United Kingdom (third country) will be subject to the provisions of health product legislation governing the import of products and the control of foreign trade.
What will happen if the authorised representantive in Europe for the health products is a company based in the United Kingdom?
As from 1 January 2021, authorised representatives that are established in the United Kingdom will not be recognised as authorised representatives for the purposes of legislation applicable to the EU on health products. Accordingly, manufacturers must take the appropriate measures to guarantee that, as from the withdrawal date, their authorised representatives are established in the EU-27 or in Northern Ireland. Importers and authorised representatives are reminded that they may be established in Northern Ireland.
In the case of Spanish companies appointed as authorised representatives by a manufacturer of class I or personalised health products located in the United Kingdom, the details and products should be notified to the AEMPS [Spanish Agency of Medicines and Health Products] Register of Persons Responsible.
What repercussions will Brexit have on UK Notified Bodies?
EU legislation on products required Notified Bodies to be based in a Member State and designated by a notifying authority of a Member State to engage in the assessment of compliance established in the corresponding EU act on the products. Therefore, as from 1 January 2021, UK Notified Bodies will lose their status of EU Notified Bodies and will be removed from the European Commission's information system on Notified Bodies (the NANDO database). Hence, British bodies will no longer be in a condition to engage in compliance assessment under the provisions of EU legislation on products following the withdrawal of the UK from the EU.
What will happen to health products certified with the CE mark by UK Notified Bodies?
As from 1 January 2021, CE marked medical devices issued by UK Notified Bodies will no longer be recognised in the EU. For those products whose evaluation has been transferred to a NO in the EU-27, a period until May 25, 2021 is granted for the adaptation of their labelling and instructions for use.
What will happen if the entity responsible for the cosmetics products is based in the United Kingdom?
As from 1 January 2021, the person responsible may not be established in the United Kingdom. This means that, if the product is manufactured in the United Kingdom, the responsible person will be the importer in the EU-27 (by default), being able to designate by written mandate as responsible entity representative another person or entity established in the EU-27 or in Northern Ireland, who will be accepted in writing. All importers established in Spanish territory must submit to the Spanish Agency for Medicines and Health Products, before the start of the activity, a Responsible Declaration on such activity.
All of the above will apply when the cosmetic product is manufactured in a third country and imported into the UK and subsequently imported into the EU-27 or Northern Ireland. Furthermore, if a responsible entity established in the UK has been designated by an EU-27 manufacturer / importer, that manufacturer / importer will need to take the necessary steps to ensure that from 1 January 2021 the responsible entity will be established in the EU-27 or Northern Ireland.
A cosmetic product going from the United Kingdom to Northern Ireland is recalled to be considered imported, while a product manufactured in Northern Ireland and shipped to the European Union will not be considered an imported product for the purposes of labelling and identification of economic operators or a responsible entity.
What repercussions will Brexit have on the Notifications on the European Portal for cosmetics products?
As from 1 January 2021, the new EU-27 responsible entity will need to file notification of the product with the CPNP before introducing the cosmetics product into the EU-27 market.
For cosmetics products manufactured in the United Kingdom, the notification will need to state that they are imported from the United Kingdom.
What repercussions will Brexit have on cosmetics products data files?
As from 1 January 2021, the data files on cosmetics products will need to be available at the address of the EU-27 responsible entity and will need to be drawn up under the necessary terms in the language of the Member State in question. If the responsible entity is based in Spain, this will be Spanish.
What repercussions will Brexit have on cosmetics product labelling?
Cosmetics product labelling must include the name and address of the responsible entity.
As from 1 January 2021, any cosmetics products manufactured in the United Kingdom and marketed in the European Union or Northern Ireland will be considered as cosmetics products imported from a third country. The country of origin will therefore need to be indicated on the labelling.
For more information, please see the website of the European Commission.
Will there be any health product availability problems when the United Kingdom leaves the EU?
All heath products, except those of minimum risk (Class I) must be assessed by the Notified Bodies. They issue the EC certificates of conformity following a positive assessment, which enables the CE mark to be applied to the products and the products to be moved around the European Union market.
As a result of Brexit, Notified Bodies established in the United Kingdom will lose their status as Notified Bodies of the European Union. Therefore, as of 1 January 2021, CE marking certificates issued by a UK Notified Body will not be valid and the manufacturer will have to apply for a new CE marking certificate from a EU Notified Body.
The competent authorities of the Member States are working on solutions and agreements to avoid the possible shortage of certain health products on the European market.
For more information visit The Spanish Agency of Medicines and Medical Devices
Non official translation