Yes. HOWEVER, if very few batches of one product are MANUFACTURED in one year, it MAY also be acceptable to conduct a two yearly PQR providing a rationale is documented and scientifically justified. The justification for a reduction in the frequency of reviews should consider whether the medicines are registered, listed or complementary, the number and size of batches manufactured, whether grouping is utilised and the METHOD of manufacture, together with an assessment of the risk associated with the product. The APPROACH taken by the manufacturer will be assessed on a case-by-case basis.

Yes. However, if very few batches of one product are manufactured in one year, it may also be acceptable to conduct a two yearly PQR providing a rationale is documented and scientifically justified. The justification for a reduction in the frequency of reviews should consider whether the medicines are registered, listed or complementary, the number and size of batches manufactured, whether grouping is utilised and the method of manufacture, together with an assessment of the risk associated with the product. The approach taken by the manufacturer will be assessed on a case-by-case basis.