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What happens if the medical devices are manufactured or distributed by a company located in the UK?
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From the date of withdrawal, a manufacturer or distributor established The United Kingdom will no longer be seen as an economic actor established in the union and therefore will be considered a company of a third country, so you will have to meet the specific obligations of a company of a third country, which are different from those of a company of UE-27. Therefore, from Brexit, corporations of our country to acquire health products in The United Kingdom (third country) will be of implementation legislation of medicinal products on import of products and foreign trade.
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What will happen if the authorized representative in europe of health products is a company located in the uk?
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From the date of withdrawal, authorized representatives who are set out in The United Kingdom will not be recognized as authorized representatives to the effects of the applicable law of the european union on medicinal products. Therefore, manufacturers should take necessary measures to ensure that, from the date of withdrawal, their authorized representatives are set out in the UE-27.
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What impact will the Brexit in respect of the Agencies of The United Kingdom?
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Union product legislation requires Notified Bodies to be established in a Member State and designated by a notifying authority of a Member State to carry out the conformity assessment tasks set out in the relevant Union product act. Consequently, from the date of withdrawal with or without agreement, UK Notified Bodies will lose their status as Union Notified Bodies and will be removed from the Commission's information system on Notified Bodies (the NANDO database). As a result, from the date of withdrawal UK bodies will not be in a position to carry out conformity assessment tasks under the provisions of Union product legislation.
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What will happen to health products with certificates of CE marking of issued by Agencies of The United Kingdom?
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With agreement
The same conditions except for moratoriums on the certificate's validity, EC has not yet been covered.
Without agreement
If economic operators have certificates issued by a Notified of The United Kingdom before the date of withdrawal and intend to continue making the market of UE-27 after that date, it will be necessary to applying for a new certificate issued by a notification of the Agency UE-27.
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What happens if the person responsible for the cosmetic products is based in the UK?
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Whether or not Brexit agreement from the date of withdrawal, the person responsible may not be established in the uk. This means that if the product is manufactured in the uk, the person responsible shall be the importer in the UE-27 (by default), by written terms of appointment as the person responsible for another person established in the UE-27, which will be accepted in writing. Any importer established in spanish territory shall submit to the spanish agency of Medicines and health products, before the start of the activity, a statement responsible on such activity.
The same shall apply when the cosmetic product is manufactured in a third country and imported in The United Kingdom and subsequently imported in UE-27. Moreover, if a person responsible established in The United Kingdom has been designated by a manufacturer/importer of UE-27, the manufacturer/importer must take the necessary measures to ensure that, after the date of withdrawal, the person responsible shall be established in the UE-27.
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What impact will the Brexit concerning Notifications in the european Portal in the field of cosmetic products?
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Whether or not Brexit agreement from the date of withdrawal, before the introduction of the cosmetic product in the market of UE-27, the new person responsible for the UE-27 will have to make the notification of the product the CPNP.
In the case of cosmetic products manufactured in the uk, in the notification shall be that are imported from The united kingdom.
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What impact will the Brexit with regard to the files of information of the cosmetic product?
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Whether or not there is a Brexit agreement, from the date of withdrawal, the cosmetic product information file will be available at the address of the responsible person in the EU-27 and will be adapted in the terms required by the language of the Member State concerned. If the responsible person is established in Spain, it will be Spanish.
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What impact will the withdrawal on the labelling of cosmetic product?
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Whether or not there is a Brexit agreement, the name and address of the responsible person must appear on the label of the cosmetic product.
From the date of withdrawal, cosmetic products manufactured in the UK and placed on the European market will be considered cosmetic products imported into the EU-27 from a third country. Therefore, it will be necessary to specify on their labeling the country of origin. For further information please consult the Commission's website.
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When the UK leaves the EU are there going to be problems of availability of medical devices?
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All health products, with the exception of minimum risk (class I) must be assessed by some agencies Agencies Are called. when the assessment is favourable EC issued certificates of conformity which allow the CE marking on products and move freely within the european union market.
As a result of Brexit, agencies Reported set out in The United Kingdom will lose their status as agencies of the european Union. Therefore, following the Brexit, CE marking certificates issued by a Notified of The United Kingdom will not be valid and the manufacturer must apply for a new certificate of CE marking into an agency Notified of the union.
The competent authorities of member states are working on solutions and agreements to prevent the possible lack of supplies of certain medical devices in the european market.
