Article: 32
Pharmaceutical production establishments means any establishment in which are carried out
on industrial scale, activities of manufacturing, analysis of drugs and other pharmaceutical
products and control of their conformity to the standards required by laws and regulations in
the country as well as their conditioning with the aim of marketing them on the national
international markets.
The pharmaceutical production establishment can import raw materials, technical scientific
material and appliances. The procedure provided for in Article 30 of this Law remains
applicable.
Article: 33
Any legal entity or individual can have authorization to open and exploit a pharmaceutical
production establishment, provided that the technical responsibility is confided to a
pharmacist.
Article: 34
The head pharmacists shall record in a register, detailed phases of manufacturing and control
analysis as well as their results. He/she will sign the conclusions drawn from them.
The register should be kept up to date. It shall be at the inspector pharmacist's disposal. It
should be kept for at least ten years from the date of its closure
Article: 35
Authorization to manufacture drugs and other pharmaceutical products should indicate
pharmaceutical form which it is valid and where they are manufactured.
Article: 36
Any pharmaceutical production establishment is required to see to it that the premises where
manufacturing operations are carried out, the staff and factory scientific equipment be
conformity with regulations of a good manufacturing practice's as recommended by the
World Health Organization.
Article: 37
For the duration validity for the drug or other pharmaceutical products and for the following
years, the head pharmacists shall put at the Pharmacy Inspectorate's disposal a sample of
products whose conformity to the official standards has been certified. The sample should
be sufficient quantity so as to allow carrying out required analysis.
Article: 38
The holder of an authorization to open and exploit a pharmaceutical production
establishment should take measures for the head pharmacists to fulfill his/her mission and, if
the case arises, to have him/her get helped by other pharmacists.