The directors of laboratories operated by legal persons must meet the same conditions as those laid down in Article 11 of Decree N° 90-1465 of 9 November 1990.
The opening and operation of a medical analysis laboratory by a legal person shall be authorized by the order of the Minister of Public Health.
Obtaining the opening authorization provided for in Article 15 above is subject to the production of a file comprising the following documents:
-an application on stamped paper indicating the name of the company, and the nature, and location of the laboratory.
-the company’s articles of association.
-the composition, if any, of the Board of Directors.
-the plan of the premises to be used for the laboratory and, if applicable, a copy of the lease agreement in lieu thereof.
-copies of the diplomas of the person who will be responsible for the technical management of the laboratory.
– a list of the technical staff to be employed in the laboratory, together with their corresponding diplomas.
The file referred to in above shall be deposited with the departmental public health service territorially competent, against a receipt.
The head of the departmental public health service shall have a period of thirty (30) days to transmit, under cover of the competent provincial delegate, to the Minister of Public Health, who, in turn, has a period of thirty (30) days to from the date of receipt to decide.
In all cases, the agreement or reasoned refusal of the Minister of Public Health must intervene within ninety (90) days following the submission of the file to the departmental public health service. After this period, the opening authorization is deemed to be granted.
Any transfer of a laboratory, any modification of its operating conditions, or any conditions of closure in the event of duly noted serious misconduct by a legal person shall be subject to the same rules as those
as those laid down in the decree.