Can anyone send a format for Module 3 for multivitamin and mineral product as we are adding overages and we do not possess any chemical compatibility test for vitamins....
Module 3: Quality
P harmaceutical-chemical and biological data for medicinal products containing chemical, active substances
Introduction
The requirements for quality are generally set out in the Danish Executive Order on vitamin and mineral products, in which it is indicated that the products “must be of a satisfactory quality”, and in the Executive Order of the Danish Medicines Agency on the quality of medicinal products (see Annex 5, item 4 for reference).
Strong vitamin/mineral products are medicinal products, for which reason they are generally subject to the same requirements for quality as other chemical medicinal products – keeping their special properties in mind. Reference is therefore made to the Rules Governing Medicinal Products in the European Union, Volume 3, Scientific Guidelines concerning EU and ICH guidelines for the quality of chemical medicinal products, cf. EMA’s websitehttp://www.ema.europa.eu .
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