Subsection 2: Medical laboratories established in another Member State of the European Union or party to the Agreement on the European Economic Area

When a medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area carries out the analytical phase of medical biology examinations begun in France, the accreditation conditions, the authorisation conditions or the approval conditions referred to in 1° and 2° of Article L. 6221-4 are recognised as equivalent to those laid down for medical biology laboratories established on…

The list of Member States of the European Union or parties to the Agreement on the European Economic Area in which the accreditation conditions, the authorisation conditions or the approval conditions for medical biology laboratories performing the analytical phase of a medical biology examination begun in France are recognised as equivalent to those imposed on medical biology laboratories established on French territory is set by order of the Minister for…

The declaration provided for in 1° and 2° of Article L. 6221-4shall be sent by the medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area to the Minister responsible for health, by electronic means or by post with acknowledgement of receipt. It must be accompanied by a copy of the documents representing accreditation, authorisation or approval issued…

The person in charge of the medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area shall inform the Minister responsible for health without delay in the event of suspension or withdrawal of the accreditation, authorisation or approval issued by the competent authorities of the State in which it is established. At any time, the Minister for Health…

When a medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area which is not on the list referred to in Article D. 6221-6 carries out the analytical phase of a medical biology examination begun in France, the authorisation provided for in 3° of Article L. 6221-4 is granted provided that its operating conditions comply with the criteria…

I.-The application for authorisation provided for in 3° of Article L. 6221-4 shall be sent by the medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area to the Minister responsible for health, by electronic means or by post with acknowledgement of receipt. II – If the medical biology laboratory is accredited in its own country under the…

The application for authorisation must be accompanied, where appropriate, by a copy of the documents representing authorisation or approval issued by the competent authorities of the State in which the laboratory is established. The application for authorisation and the attached documents must be accompanied by a certified translation into French.

Applications for authorisation may only be examined if they are accompanied by a complete file. The application is deemed to be complete if, within one month of receipt, the Minister for Health has not informed the applicant, by registered letter with acknowledgement of receipt, of the list of missing or incomplete documents.

The authorisation is issued for a period of five years. It specifies the medical biology tests or families of medical biology tests that the laboratory is authorised to perform at the request of a medical biology laboratory established on French territory.

The competent authorities of the State in which the laboratory has its registered office are informed of the decision of the Minister for Health.