Noting the challenges while implementing the provisions of the Bhutan Medicines Rules and Regulation 2012; the Bhutan Medicines Board instituted as per Chapter II section 4 of the Medicines Act of the Kingdom of Bhutan 2003 has endorsed the addition/ amendment of following sections in the Regulation.
Qualification for registration a Competent Person
Existing clause of the Bhutan Medicines Rules and Regulation 2012:
139 ‘For registration of competent person for manufacture of medicinal products, the person shall have a Diploma in relevant field with minimum of working experience of five years in their related field.’
Additional Clause approved in 12th Bhutan Medicines Board Meeting:
139 ‘For registration of competent person for manufacture of medicinal products, the person shall have a bachelor degree in relevant field with minimum of working experience of two years in their relevant field.’
Effective date: 2nd May, 2014
Renewal of Technical Authorization for Sale and Distribution
Amendment of section 127 of the Bhutan Medicines Rules and Regulation 2012
127(a) ‘Non-renewal of technical authorisation within the period provided under section 125 and section 126 of this Regulation, the technical authorization shall be suspended and a fine of Nu. 10000(ten thousand only) shall be levied for renewal of the authorization.’
Section 127(b) ‘Non-renewal under section 127(a) above shall be dealt as per section 29(e) of the Medicines Act of Kingdom of Bhutan 2003 for closure of premise and seizure of goods and 30 working days of notice for renewal as per section 127(a) shall be provided.’
Effective date: 21st September 2014
Therefore, all the relevant agencies and clients are required to note above amendments which are enforced by DRA. For further information, please contact Registration Division, DRA at 02-337076.
This is issued for compliance by affected agencies and stakeholders.
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