In Turkey, pharmaceutical warehouses which provide secondary packaging services such as inserting patient information leaflets, labelling, price printing in addition to the basic storage services are classified as responsible warehouses. According to the Regulation Regarding the Pharmaceutical Warehouses and Products Located in Pharmaceutical Warehouses, a responsible warehouse permit is necessary to be issued for these entities by the Ministry of Health (“MoH”). According to the recent announcement of the MoH, warehouses providing secondary packaging services shall be evaluated as manufacturing facilities and further procedural requirements will be applied.
Manufacturing facilities are subject to the provisions of the Regulation on Manufacturing Plants of Pharmaceuticals and Good Manufacturing Practices Guideline. In order to obtain a manufacturing plant permit, any real or legal entity satisfying the general conditions (i.e. employing a responsible manager with a degree of pharmacy, medicine or chemistry; employing certain personnel, documenting that the facility satisfies the technical requirements, compliance with the good manufacturing practices requirements) and possessing the required documents can apply to the relevant authorities. Going forward, as the pharmaceutical warehouses providing secondary packaging services will be evaluated as manufacturing facilities, requirements for operation and authorization of manufacturing plants shall be applicable to these warehouses.
Under this approach, warehouses currently providing secondary packaging services are required to apply to the MoH by July 31, 2017 to initiate the procedures for issuance of a manufacturing plant permit and completion of a site inspection. The most important consequence of this new system is expected to be the need to comply with the good manufacturing practices by these warehouses and increase in the quality requirements applicable to warehouses even for secondary packaging activities.