Herbal Medicinal Products (Amendment) Regulations, 2012

L.N. 370 of 2012

MEDICINES ACT

(CAP. 458)

Herbal Medicinal Products (Amendment) Regulations, 2012

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Minister of Health, the Elderly and Community

Care, after consultation with the Licensing Authority, has made the

following regulations:-

(1) The title of these regulations is the Herbal Medicinal Citation and

Products (Amendment) Regulations, 2012, and these regulations shall scope.

be read and construed as one with the Herbal Medicinal Products S.L. 458.44

Regulations, hereinafter referred to as the "principal regulations".

(2) These regulations implement the provisions of Directive

2010/84/EU of the European Parliament and of the Council of 15

December 2010 amending, as regards pharmacovigilance, Directive

2001/83/EC on the Community code relating to medicinal products

for human use.

Sub-regulation (1) of regulation 9 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(1) The following provisions shall

apply, by analogy, to traditional use registration

granted under these regulations

(a)

articles 2(a), 2(b), 28(1), (2)

and (6), 102, 104A(1) and 110(4) of the

Medicines Act;

(b) regulations 4(1)(a) and (b), 9,

12, 15(1) and (2), 18(1), (2) and (3), 19,

20, 26, 27, 28, 29 and 30 of the Medicines

(Marketing Authorisation) Regulations;

(c)

the Good Manufacturing

Practice in respect of Medicinal Products,

Active Substances and Investigational

Medicinal Products for Human Use

Regulations;

(d) the

Manufacture

and

Importation of Medicinal Products for

Human Use Regulations; and

(e)

the

Pharmacovigilance

Regulations, 2012.".

€0.18