PART 6Certification of homoeopathic medicinal products
Revocation, variation and suspension of certificate of registration
Revocation, variation and suspension of certificate of registration110
1
The licensing authority may revoke, vary or suspend a certificate of registration if any of the following conditions are met.
2
Condition A is that the licensing authority thinks that—
a
the product to which the certificate relates is harmful;
b
the risks of the product to the health of patients or of the public outweigh any beneficial effects of the product; or
c
the product's qualitative or quantitative composition is not as described in the application for the certificate or the material supplied with it.
3
Condition B is that the licensing authority thinks that the application or the material accompanying it is incorrect.
4
Condition C is that the licensing authority thinks that there has been a breach of—
a
a term of the certificate; or
b
a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).
5
Condition D is that the licensing authority thinks that a condition to which the certificate is subject by virtue of regulation 105 (conditions of certificate or registration) has not been fulfilled.
6
Condition E is that the licensing authority thinks that the holder of the certificate has not complied with regulation 115(1) to (3) (requirements to provide information).
7
Condition F is that the holder of the certificate has ceased to be F2established in—
a
the United Kingdom; or
b
in relation to a COR(NI), either the United Kingdom or the European Union,
in accordance with the requirements of these Regulations.
8
Condition G is that—
a
the holder applies to vary the certificate; and
b
the licensing authority thinks that the application should be granted.
F18A
Condition H is that the manufacture and control of the product to which the certificate relates is not in compliance with the particulars provided under regulation 103(8)(c) and (d).
F38B
Condition I is that the licensing authority thinks that the revocation, variation or suspension is necessary or expedient in light of the Protocol on Ireland/Northern Ireland in the withdrawal agreement.
9
Schedule 11 makes provision about advice and representations in relation to a proposal to revoke, vary or suspend a certificate of registration, other than a proposal to vary a certificate on the application of its holder.
10
This regulation is subject to regulation 111 (certificates granted under Chapter 4 of Title III of the 2001 Directive).