FAQ: Medicinal products for human and veterinary use

What happens if i am an entrepreneur holder of a marketing authorisation of a drug and i established The United Kingdom?

In order to maintain effective consent and to continuing to marketing the medication in the eu must be transferred authorizing a headline which lies in the eu/eea, and this should be achieved by 30 march 2019.

What happens if i am an entrepreneur seeking a marketing authorisation of a drug and i established The United Kingdom?

The request to be transferred to an applicant established in the eu/eea before 30 march 2019.

What happens if the manufacturing plant of an active substance of one of my medicines is located in the UK?

Whether or not Brexit agreement, in accordance with european rules the person must reside pharmacovigilance and carry out their responsibilities in a state member of the eu/eea. Accordingly, you should change their residence and to carry out its activities since the eu/eea, or the incumbent will propose a new pharmacovigilance fulfil this requirement.

What happens if the active substance of one of my medicines is located in the uk?

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.

What happens if the completed my medication is located in the uk?

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.

When the UK leaves the EU are there going to be problems with drug availability?

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.

What can i do if by reason of departure of The United Kingdom there are a problem of supplying a veterinary medicine?

• 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.

May I have difficulty in accessing my medication provided through the service of Foreign Medication?

Medicines administered in special situations will continue to be provided as until now, regardless of their origin is a United kingdom.