If your company is established in any of the 27 member states of the european Union (UE-27) or in a state member of the european economic area (EEA), will be affected by the departure of the united kingdom of the eu if their supply chains as a customer or supplier stretch to the United kingdom.

If your provider or client is established in the uk, please note that, since his departure from the eu, the existing community legislation on chemicals, including REACH, CLP, RPGS, DPI and PIC does not apply in the united Kingdom.

Get ready to identify its current role in the supply chain and their suppliers and customers of the united kingdom. This will determine how it will affect the Brexit.

Scenario without agreement

• Shall cease to apply to The United Kingdom standardsEUwhich protect industrial property rights.
• Shall cease to be protected in The United Kingdom human, which is held by a company or eu citizen, who are already registered at european level (mark of the EU) in the office for intellectual property of the european union (EUIPO) or in the community Register of geographical indications.
• Keep only those rights that have been registered or recorded directly in the office for the rights of The united kingdom.
• Lost in The United Kingdom seniority of the right recognized at european level.
• Nor can it be implemented in Uk opposition proceedings of eu brands. Delegations are reminded that the request of marks to the relevant office of The United Kingdom may involve the payment of fees that its legislation on brands to protect that right.
• Given the uncertainty, it is recommended that the incumbent of the right to assess the need to initiate the procedure for registration of marks on The united kingdom.

Stage with agreement

• Agreementthe incumbent of one of these rights registered in the european union in accordance with EU regulations (Regulation (EU) 2017/1001 on brands of the european parliament and the council, and the regulations governing geographical indications Regulation 1308/2013 (wine), regulation 110/2008 (spirits), Regulation 251/2014 (aromatized wine products) and Regulation 1151/2012 (other agricultural products and foodstuffs)) will become the owner of other rights in The United Kingdom of the same sign, for the same goods or services.
• Future relationshipshows the commitment of The United Kingdom and the eu to establish a mechanism for cooperation and exchange of information on intellectual property issues of mutual interest, such as the respective approaches and processes relating to trademarks, designs and patents, as well as other titles of industrial property, if any (utility models, etc).

The RD act allows nationals of the united kingdom, spanish or citizens of other eu countries continue to exercise his profession as until now, with the qualification and other requirements brought.

It is envisaged that applications for approval of academic degrees and recognition of professional qualifications are governed by the legal regime leading to the withdrawal, provided that it has been initiated before the date of withdrawal and subject to certain time limits and limitations.

As regards the exercise in Spain an occupation or profession in temporary or occasional, and within the framework established, may continue to do with the sole purpose of fulfilling existing contracts to the date of withdrawal of The united kingdom.

In this article is conditional on the granting of reciprocal treatment by the british authorities.

Exit without agreement

• Its supplier of Industrial Chemicals (REACH) is in the united Kingdom

  Your provider of the united kingdom is no longer be obliged to comply with the rules of procedureREACHbut national legislation on chemicals to be adopted in the united kingdom.

  The registers of substances and authorizations already issued its supplier of the united kingdom are no longer valid.

  In short, you will no longer be downstream user and will become importer in relation to its supplier of the united kingdom.

  However, your provider of the united kingdom has two options for maintaining their registrations and authorisations REACH

  1. May appoint as exclusive representative in order to REACH an enterprise UE-27/EEA
  2. You can move their operations to an enterprise UE-27/EEE making a change of legal entity.

  In which case you remain downstream user of the vendor.

  Get ready to consult with your provider of the united kingdom about its intentions on the market UE-27/EEE after Brexit.

• Your provider community not Industrial Chemicals (REACH) has the exclusive representative in the kingdom Aleft

  If the exclusive representative your provider is not a uk company, you can not remain after Brexit.

  Your service provider in the eu must decide whether to appoint another representative established the exclusive UE-27/EEA or ceases to have the exclusive representative.

  Get ready to consult with their non-european supplier on its intention to designate another representative in the exclusive UE-27 after Brexit.

• His client, which provides Industrial Chemicals (REACH), is in the united Kingdom

  If you have clients in the united kingdom, from Brexit you will be marketing their products to a non-eu country, so that this will not export and internal trade.

• Your company, which sells Industrial Chemicals (REACH), is a subsidiary of a uk company

  If your legal entity is the holder of registries and/or authorizations for substances that sold in the UE-27/EEA or is the exclusive representative manufacturer of a community, their situation after Brexit will remain the same as today.

  If the legal entity, holder of registries and/or authorizations for substances and mixtures which are traded on the UE-27/eea agreement is the parent company in the united Kingdom, it must decide what action on the market UE-27/EEE after Brexit.

  If the legal entity of the united kingdom is designated as the exclusive representative of a non-community manufacturer, after Brexit does not become manufacturer. If the non-community wishes to continue to have an exclusive representative, must appoint a new record in the UE-27/Eea.

  In this scenario, the matrix of the united kingdom or the manufacturer non eu respectively, could choose their legal entity to undertake the responsibilities of the matrix of the united kingdom. In that case, please note that

  • The decisions and steps must be taken before the Brexit enters into force and registration/authorization from the UK companies cease to exist.
  • Prepare reports on the intentions of its parent company of the united kingdom, their situation in the supply chain can change.
  If you are going to be designated as the exclusive representative or transferring the manufacturing operations/import, to take into account the deadlines in order to avoid supply disruptions
  .

Departure with the agreement

In the case that the departure of the united kingdom is done with the agreement, there will be a transitional period during which it will continue to apply community rules in the united Kingdom.

Remember that pending the entry into force on Brexit, companies in the united kingdom all legal obligations of REACH.

TheEuropean Chemical substances and mixtures(CHECK) has a link where you can find frequently asked questions and answers regarding the Brexit.

The loss of the eu passport means that the british financial entities will have to adapt to the regimes of third countries to continue to provide services in Spain, including those services resulting from contracts concluded before, but later due to the withdrawal of the united kingdom with the aim to strengthen legal security, the protection of the client and avoid any risk for financial stability, the royal Decreto-ley noted that the validity of contracts is not affected by the withdrawal of the united kingdom, a fact that the european commission has already been evident in its communications.

It sets out a temporary regime to ensure that adaptation to the regimes of third countries does not involve a disruption in the provision of services associated with such contracts or, alternatively, to facilitate the relocation or termination of contracts where the entity does not wish to stay in business in Spain. The temporary regime for the activities subject to authorization. The activities related to the management of contracts that do not require authorization may continue without recourse to temporary regime.

Yes, without prejudice to the transitional provisions that might be contained in the arrangement in the form of withdrawal from the date of withdrawal (30 march 2019) will cease to apply to the united kingdom the rules of the union in the field of non-food products and non-agricultural products for use by consumers and professionals.

As a result, from the date of withdrawal, the United Kingdom should be considered, for the purposes of the above-mentioned harmonized legislation, as a third country. You can consult the rules applicable to products from third countries in theBlue 'Guide on the implementation of the european regulations concerning products (relevant text for the purposes of the eea).

The products enter the market of the europe of 27 (‘ UE-27 ') from the date of withdrawal of the united kingdom (30/03/2019). You can consult the indicative list of products involved in the annex to the Communication with stakeholders in the european commission on the withdrawal of the united kingdom and european union regulations in manufacturing. (provides as a document of interest).

The concept of “ onto the market ” refers to each individual product, not a type of products, whether it has manufactured as a unit individually or in series. Refers to the first put back on the market in the european (UE-27), that is, the first provision of an asset for distribution, consumption or use after the stage of manufacture.

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.

Whether or not Brexit agreement, upon the departure of the united kingdom of the eu active substances as manufactured in that country shall be considered as active substances imported.

In accordance with european rules, it requires that drug manufacturers use only active substances as manufactured according to the good manufacturing practices starting materials shall be subject to inspection by the authorities of the eu as a third country.

Regulates the transitional situation where the economic operators of the United kingdom and Gibraltar on public procurement procedures. This regulation aims to provide legal certainty and to avoid harm to those economic operators that relied on the european project and participated in procurement procedures initiated prior to the withdrawal of the united kingdom of the european Union, tutelándose well the interests of the economic operators who exercised their right to freedom of movement under the freedoms granted by the treaties in the field of public procurement In these cases, the british economic operators will have the same status as companies belonging to States members of the european Union. This situation is also consistent with the transitional law which has been to govern public procurement in Spain.

It is also expected that the public procurement, if any, must be held for the implementation of the measures referred to in the royal Decreto-ley, recruitment files can be the subject of urgent processing or handling of emergencies, in accordance with the provisions of law 9/2017, of 8 november, on public Sector contracts.

From the date of withdrawal, a manufacturer or importer established the united kingdom will no longer be seen as an economic actor established in the union. Therefore, an economic actor established the UE-27 that, before the date of withdrawal, was considered a distributor of the eu will become from the date of withdrawal, for the purposes of the union's legislation on products, an importer that introduces products from a third country in the market of UE-27. This will have to keep to the specific obligations of an importer, which are different from those of a dealer.

You can consult the obligations of economic agents in chapter 3Blue 'Guide on the implementation of the european regulations concerning products (relevant text for the purposes of the eea).

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.

Similarly in the previous case, upon the departure of the united kingdom of the eu drugs made in that country shall be treated as imported medicines. to continue with a provision to the eu/eea Brexit as before, by 30 march 2019 should have adapted the registration of pharmaceuticals manufactured in the united kingdom, including in the same a TAC and a liberator of the drug located in the eea.

Otherwise, the competent authorities of the eu/eea will ensure that the import of drugs on its territory is subject to authorization in accordance with european standards. Will be subject to inspection by the authorities of the eu as a third country.

Whether or not Brexit agreement, after the effective implementation of the united kingdom of the eu drugs from this country must be imported by a pharmaceutical laboratory importer.

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.

The authorities of the eu have months to report to the holders of marketing authorisations for the legal obligations on pharmacovigilance, ownership, manufacture, etc. Currently, the majority of medicines have successfully resolved. Those that have not been solved and fail to do so in time, you will see suspended their authorisations on 29 march 2019.

In parallel, together with all member States and the european medicines agency (EMA), for this there are risks or shortcomings condoms or as a result of therapeutic Brexit. The potential risks and are scarce and this is looking for alternatives so that there are in practice such problems.

Take measures to enable the carriage of goods made by carriers established in the united Kingdom in our country, provided that such companies are authorized to make transport in that country, except for liberalised transport currently on eu legislation.

States, as a framework of implementation to the transport of passengers on discretionary bus made in spanish territory by companies based in the united kingdom, under international treaties to which are party to both the united kingdom and Spain or the european Union, or the envisaged under the norms of international organizations that are members of both the united kingdom and Spain or the european union, as from 1 april, the United Kingdom will be integrated as a full member of the agreement Interbús.

Moreover, reflected the validity, until their expiry date of shipment authorizations international passenger regulation currently in force between the territory of the united kingdom and spain.

YES, for products sold in the market of UE-27 after the date of withdrawal, both the declaration of conformity of the eu (developed by the manufacturer) as the certificate of the agency reported must be updated accordingly; these documents should mention that the certificate is now under the responsibility of a notification of the agency UE-27 must indicate the numbers of former agency of the United Kingdom and the new agency UE-27 reported.

If the product is in the market, you can stay with no british agency next to the CE marking if it has been produced or put on the market before the transfer of certificates. However, the products made after the transfer of certificates must update their marking, referring to the number of the new agency reported.

• If you browse a veterinary medicine, european and national legislation provides that

  The exceptional prescribe a veterinary medicine of another member state or of medicinal products for human use authorized in Spain.

• If there are no medicines from the previous subparagraph, may be obtained from the AEMPS exceptional import a veterinary medicine or a medicine for human use.
• In cases of serious animal diseases that so warrant, or where mandatory health regulations for the import or export of animals, AEMPS may authorize the import of a proper immunological veterinary medicine, subject to mandatory report by the ministry of agriculture, fisheries and food.

With regard to the airport services, the departure of the united kingdom of the european Union would be discontinued as rates of shipment and provision of catering services planned for flights within the european economic area.

Therefore, it is envisaged to the maintenance of these fares for flights to the united kingdom until 28 february 2020.

The union's legislation on the type-approval will no longer apply to and the united Kingdom, from the date of withdrawal.

Every manufacturer a type-approval of the united kingdom which has not ceased to be valid under article 17 of directive 2007/46/ec, article 32 of the rules of procedure (EU) no. 167/2013, rule 37 of the rules of procedure (EU) no. 168/2013 or article 30 of the rules (EU) 2016/1628 may portray authority of the type-approval of the union a request of the type-approval of the same type, before the date of withdrawal.

To be authorised, the type must meet at least the requirements for the introduction in the market, registration or commissioning of new vehicles, systems, components or independent technical units effect at the date on which the effect of type-approval of the union.

The manufacturer shall be required to pay rates, established by the authority of the type-approval of the union, for any resulting cost of the exercise of powers and the implementation of the obligations of the authority of the type-approval of the union in relation to the type-approval of the union.

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.