Provisions to which the marketing authorisation is granted

1. All the provisions of Part I of Schedule 1 of the Medicines (Standard Provisions for  Licences and Certificates) Regulations 1971 (SI 1971 No 972) and any provision of those regulations as amended by the Medicines (Standard Provisions for Licences and Certificates) Amended Regulations 1972 (SI 1972 No 1226), the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1974 (SI 1974 No  1523) and the Medicines (Standard Provisions for Licences and Certificates) Amendment Regulations 1977 (SI 1977 No 1039) shall apply.

2. If the product consists wholly or partly of antigens, antitoxins, sera, antisera, toxins or vaccines within the meaning of the Medicines (Exportation of Specified Products for Human Use) Order 1971 (SI 1971 No 1198) then, in addition, the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971 (SI No 972) as amended by the Medicines (Standard Provisions for Licences and Certificates) Amendment  Regulations 1977 (SI 1977 No 675) shall also apply.

3. Leaflets issued with proprietary medicinal products shall comply with the requirements of the Medicines (Leaflets) Regulations 1977 (SI 1977 No 1055). Labels of medicinal products shall comply with the Medicines (Labelling) Regulations 1976 (SI 1976 No 1726) as amended by the Medicines (Labelling) Amendment Regulations 1977 (SI 1977 No 996), the Medicines (Labelling) Amendment Regulations 1981 (SI 1981 No 1791) and the Medicines (Labelling) Amendment Regulations 1985 (SI 1985 No 1558).

4. The product(s) shall not be recommended to be used for any purposes other than those specified in Part 1 of this Schedule as Clinical Indications.

5. The product(s) shall be manufactured only in accordance with the information submitted to the licensing authority in connection with the application for this product licence or any variation of this licence which is approved by the licensing authority: this applies in particular to information relating to -
a. the specification of the constituents of the product
b. the specification of the finished product
c. the method of the manufacture of the product and
d. the person(s) specified as the manufacturer of the product.