Consultation on Proposed Health Products Regulations 2018

Agri-Food and Veterinary Authority (Regulatory Programmes Department)

Consultation Period: 15 Nov 2017 - 15 Dec 2017

Status: Closed

Detailed Description

Aim

1 The Agri-Food and Veterinary Authority (AVA) is seeking feedback on the proposed Health Products (Supply and Use of Therapeutic Products for Veterinary Purposes) Regulations 2018, which is targeted to come into effect in the first quarter of 2018.

Background

2 The legislative controls for Therapeutic Products (TP) were ported over from the Medicines Act and Poisons Act to the Health Products (Therapeutic Products) Regulations 2016 under Health Products Act (HPA) (CAP 122D) on 1 November 2016 by the Health Sciences Authority (HSA). TP refer to medicines that are formulated and intended for use in humans but may also be used off label for veterinary purposes. However, the Therapeutic Products Regulations cover the regulation of TP for human use only.

3 To ensure prudent use of and access by the veterinary sector to TP, AVA is developing the subsidiary legislation under Section 73 of the HPA to regulate the supply and use of TP for veterinary purposes.

4 As an interim measure to ensure that the veterinary industry has continued access to TP for veterinary purposes and prepare companies for licensing, registration of the wholesalers of TP for veterinary purposes was implemented on 20 October 2016.

Proposed Key Legislative Changes

5 The key changes that will be introduced in the regulation of TP for veterinary use include the following:

(a) Licensing of wholesalers which supply TP for veterinary use,

(b) Supply of TP by wholesale can only be made to

i. veterinarians,

ii. veterinary centres or

iii. farms in accordance with a valid prescription issued by a veterinarian;

(c) Supply of TP by retail sale is restricted to

i. veterinarians for animals under their care, or

ii. pharmacists in accordance with a valid prescription issued by a veterinarian;

(d) Duties of suppliers of TP

i. Duties concerning storage and handling

ii. Duty to comply with enforcement requirements

iii. Duty to maintain records of receipt and supply

iv. Duty to report defects and serious adverse reaction and recall

6 The scope of the regulation would cover prescription-only medicine and pharmacy-only medicine (i.e. Parts 1 to 3 of the Second Schedule in the Health Products (Therapeutic Products) Regulations 2016). General sale list medicine will not be included in the regulation.

7 A detailed description on the proposed Health Products (Supply and Use of Therapeutic Products for Veterinary Purposes) Regulations 2018 can be found in the ANNEX.

Request for comments

8 AVA invites views and comments on the proposed Health Products (Supply and Use of Therapeutic Products for Veterinary Purposes) Regulations 2018.

9 Please provide your name, the organisation you represent, mailing address, contact number and email address to enable us to follow up with you to clarify any issues, if necessary. Where possible, you should highlight the specific regulation in the proposed draft you are providing your comments on. All submissions should be clearly and concisely written, and should provide a reasoned explanation for any proposed revisions.

10 Please note that the contents of any written feedback submitted, and the identity of the source, may be disclosed at the conclusion of this consultation. You may request for the feedback provided to be treated with confidence on grounds that the information is proprietary, confidential or commercially-sensitive. Such requests will be taken into consideration.

11 Please email your feedback using the prescribed template below to Christine_he_lee@ava.gov.sg.

12 Submissions should reach AVA no later than 6:00 p.m., 15 December 2017.

Annex [PDF, 542 KB]

Feedback Form [DOCX, 34 KB]