PART 6Certification of homoeopathic medicinal products
Application for certificate of registration and consideration of application
Conditions of certificate of registration105
1
The licensing authority may—
a
grant a certificate of registration subject to conditions; or
b
vary or remove a condition to which the certificate of registration is subject.
2
The powers in paragraph (1) may be exercised only after consultation with the applicant for the certificate or (as the case may be) its holder.
3
The power in paragraph (1)(a) to grant an authorisation subject to conditions may be exercised only—
a
in exceptional circumstances; and
b
when the applicant can show that the applicant is unable to provide comprehensive data on the safety of the medicinal product under normal conditions of use.
4
The conditions must relate to a matter addressed by Annex I to the 2001 Directive.
5
The conditions may, in particular, relate to the safety of the product to which the certificate relates.
6
The conditions may, in particular, require that, where there is an incident relating to the use of the product—
a
the incident must be reported to the licensing authority; and
b
such other action as may be specified in the conditions must be taken.
7
The licensing authority must keep under review—
a
the conditions to which a certificate of registration is subject; and
b
the holder's compliance with those conditions.
8
The licensing authority must consider those matters no less frequently than—
a
at the end of the period of one year beginning with the date on which the certificate was granted; and
b
at the end of each subsequent period of one year.
9
Schedule 11 makes provision about advice and representations in relation to proposals to vary or remove a condition to which a certificate of registration is subject.