The application for administrative authorisation provided for in Article L. 6211-2 as it read prior to the entry into force of Order No. 2010-49 of 13 January 2010 as amended relating to medical biology, submitted in the cases described in 1° and 1° bis of III of Article 7 of the said Order, as amended by Law No. 2013-442 of 30 May 2013, shall be sent by registered letter with…
The decision of the Director General of the Regional Health Agency is notified to the interested party by registered letter with acknowledgement of receipt. It will be published in the journal of administrative acts of the department and region in which each of the laboratory’s sites is located.
Each time a change is made to one of the elements listed in Article D. 6221-24, the declaration provided for in the fourth paragraph of Article L. 6211-2 as it read prior to the entry into force of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology must be made to the Director General of the Regional Health Agency, within a period of one month.
Withdrawal of authorisation may be ordered by the Director General of the Regional Health Agency where it has been established, through an inspection carried out pursuant to Article L. 6231-1, that the laboratory is operating under conditions that are dangerous to public health. This decision to withdraw authorisation may only be taken after the head of the laboratory has been given the opportunity to present his observations on the facts…
For the application of 4° and 5° of I ofArticle 7 of Order no. 2010-49 of 13 January 2010 as amended relating to medical biology, at least one examination per family of medical biology examinations shall be accredited, the percentage being calculated on the basis of all the medical biology examinations performed by the laboratory. The medical biology examinations are calculated in accordance with the conditions set out in Article…
The medical biology laboratory shall inform the regional health agency within whose jurisdiction it is located electronically that it has obtained accreditation for the various percentages set out in I ofArticle 7 of Order No 2010-49 of 13 January 2010 as amended relating to medical biology, enclosing a detailed list of the medical biology examinations performed under accreditation.
When a medical biology laboratory established in another Member State of the European Union or party to the Agreement on the European Economic Area and appearing on a list established by order of the Minister for Health, issued after consulting the committee referred to in Article L. 6213-12, carries out the analytical phase of a medical biology laboratory examination begun in France, the conditions for accreditation, authorisation or approval of…
The declaration provided for in the second paragraph of Article L. 6211-2-1, as it stood prior to the entry into force of amended Order No. 2010-49 of 13 January 2010 relating to medical biology, shall be sent by the laboratory to the Minister for Health by registered letter with acknowledgement of receipt. It shall be accompanied by a copy of the accreditation, authorisation or approval issued by the competent authorities…
The head 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 of any 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 may request a copy of the laboratory’s valid accreditation, authorisation or approval.
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is a Registered Trademark of
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75001, Paris France
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