Paragraph 21 Standard variation application for a homoeopathic medicinal product

A standard variation application for a homoeopathic medicinal product is an application for a variation of a marketing authorization for a national homoeopathic product which requires—

(a)

the replacement of an excipient used in the manufacture of the product;

(b)

the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;

(c)

a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;

(d)

a change to the method of manufacture of a homoeopathic stock included in the product;

(e)

a change to the specification of any reagent or excipient used in the manufacture of the product;

(f)

a change to the finished product specification of the product;

(g)

a change to the test procedure for any raw material used in the manufacture of the product;

(h)

a change to the test procedure for the product;

(i)

a change to the test procedure for the container or other form of packaging immediately in contact with the product;

(j)

a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a Member State;

(k)

a change to the shape of the container in which the product may be placed on the market;

(l)

an additional pack size in which the product may be placed on the market;

(m)

a change to the approved storage conditions for the product;

(n)

a change to the shelf life of an unopened container of the product after the container has been opened for the first time;

(o)

a change to the dimensions of an approved dosage form of the product (for example, tablets); or

(p)

a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive.