You are in:

HEALTH AND COSMETICS PRODUCTS

What will happen if the health products are manufactured or distributed by a company based in the United Kingdom?

After the UK withdraws from the EU, 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 representative in Europe for the health products is a company based in the United Kingdom?

After the UK withdraws from the EU, any authorised representatives based in the United Kingdom will no longer be recognised as authorised representatives for the purpose of legislation applicable in the EU governing health products. Hence, manufacturers will need to take the necessary steps to ensure that their authorised representatives are based in the EU-27 after the withdrawal by the UK from the EU.

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, following the withdrawal with or without an agreement, 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?

With the Withdrawal Agreement

The same conditions are maintained unless a moratorium is granted for the validity of the EC certificate, a possibility that has not yet been considered.

Without the Withdrawal Agreement

If economic agents hold certificates issued by a Notified Body of the United Kingdom before the withdrawal date and they plan to continue introducing the product in the market of the EU-27 after said date, it will be necessary to apply for a new certificate issued by a Notified Body of the EU-27 or which organises a transfer (on the basis of a contractual agreement between the manufacturer, the NB of the UK and the NB of the EU-27) of the dossier and the corresponding certificate of the NB of the UK to an NB of the EU-27, which will assume responsibility for this certificate. The change of NB responsible for the EC certification will require a change of CE mark and the adaptation of the labelling of the products already manufactured.

What will happen if the entity responsible for the cosmetics products is based in the United Kingdom?

As from the withdrawal date, 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.

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.

In the case of medical products marketed in Spain, do I have to carry out any additional procedures?

Yes, it will need to update the marketing communications made to the AEMPS through the CCPS.

What repercussions will Brexit have on the Notifications on the European Portal for cosmetics products?

Whether or not a Brexit agreement is approved, 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 after the withdrawal of the UK from the EU.

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?

Whether or not a Brexit agreement is approved, 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 after the withdrawal of the UK from the EU. If the responsible entity is based in Spain, this will be Spanish.

What repercussions will the withdrawal have on cosmetics product labelling?

Whether or not a Brexit agreement is approved, cosmetics product labelling must include the name and address of the responsible entity.

Following the withdrawal, any cosmetics products manufactured in the United Kingdom and marketed in Europe will be considered as cosmetics products imported into the EU-27 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 health 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, the Notified Bodies based in the United Kingdom will lose their status of EU Notified Bodies. Therefore, any CE mark certificates issued by a UK Notified Body will not be valid after Brexit and the manufacturer will need to apply for a new CE mark certificate from an EU Notified Body.

The competent authorities in the Member States are working on solutions and agreements to avoid a possible shortage of certain health products in the European market.

For more information visit The Spanish Agency of Medicines and Medical Devices

Non official translation