Article 4 Transitional exemption from manufacturer's licences

Until such day as section 16(4) of the Act (transitional examption from manufacturer's licence) ceases to have effect by an order for that purpose under section 17 of the Act (termination of transitional exemption) the restrictions imposed by section 8(2) of the Act shall not apply to the manufacture or assembly of any medicinal product in respect of which a product licence other than a licence granted under section 26 of the Act (licence of right) has been granted if the person who so manufactures or so assembles is a person to whom the provisions of the said section 16(4), as having effect subject to the proviso thereto (operations which were included in manufacture or assembly during 12 month period prior to first appointed day), apply and have effect in relation to his manufacture or assembly of other medicinal products in the course of a business carried on by him, provided that that medicinal product is manufactured or assembled in accordance with that product licence.

Until such day as section 16(2) of the Act (transitional exemption from product licence) ceases to have effect by an order for that purpose under section 17 of the Act, the restrictions imposed by section 8(2) of the Act shall not apply to the manufacture or assembly of any medicinal product to the order of a person who is not the holder of a product licence in respect of that product provided the provisions of section 16(2) of the Act apply to that person in relation to that product and provided the licensing authority has not signified its disapproval of such manufacture or assembly.