Trade Announcements

1 July 2009 – Export sale of codeine cough preparations will require prior authorisation from HSA
HSA has noted an undesirable trend of stocks of codeine cough preparations being diverted from the legitimate supply chain into the illicit market, and encountered repeated cases in which consignments of codeine cough preparations that had supposedly been exported out of Singapore instead ended up in the possession of unlicensed suppliers in Singapore.
HSA has reviewed the controls that are applicable to the wholesale sale of codeine cough preparations, and in particular the sale of such preparations to be exported from Singapore, and has decided to tighten the controls in this respect.
With effect from 1 July 2009, the following licence condition will be attached to all poisons licences :
You shall not sell any codeine cough preparation to be exported from Singapore except with the written authorisation of HSA.
In effect, any licence holder who intends to sell a consignment of codeine cough preparation to be exported from Singapore will need to obtain authorisation from HSA beforehand. Please note that it is an offence for a poison licence holder to sell any poison in breach of the conditions attached to the poisons licence.
Should you wish to submit a request for such an authorisation, or if you require any further information or clarification on this matter, please contact HSA's Enforcement Branch:
Tel. 68663485                                                 
E-mail: hsa_is@hsa.gov.sg
 
 
16 June 2009 - Acetic Anhydride will be regulated under the Environmental Protection and Management act by National Environment Agency (NEA) from 1 July 2009

The Health Sciences Authority (HSA) wishes to inform companies dealing in Acetic Anhydride that the regulation of Acetic Anhydride will be transferred to the National Environment Agency (NEA) from 1 July 2009. Companies with a valid Form A Poisons Licence issued by HSA may continue to deal in Acetic Anhydride until the expiry of the existing licence, after which a Hazardous Substances Licence will be required from NEA.

HSA and NEA have determined that based on the usage and hazardous profile of Acetic Anhydride, it is more appropriate for Acetic Anhydride to be regulated under the Environmental Protection and Management Act. With this change, Acetic Anhydride will not be regulated under the Poisons Act and companies dealing in Acetic Anhydride will no longer be required to apply for a Form A Poisons Licence from HSA.
 
Companies requiring additional information on the Environmental Protection and Management Act, and the new licensing requirements may contact NEA at:

Telephone enquiry : 67319665
E-mail enquiry: nea_pcd_hs@nea.gov.sg


15 April 2009  - Update on Product Licence Renewal and CPP Submission

Under this new auto-renewal scheme , the renewal of product licences will be automated upon GIRO payment of the licence retention fee. Automated renewal notification will be sent to the product licence holder 60 days prior to the expiration of the product licence. The GIRO transaction will be triggered 30 days before the date of licence expiry. No action from the product licence holder is required upon receipt of the notification unless the product licence is intended to become void. In such instance, the licence holder should notify HSA via PRISM of its intention before the GIRO payment takes place.

As the auto-renewal system is tied to the GIRO payment, this scheme is applicable to licence holders who have existing GIRO accounts with HSA. For licence holders who have not applied for a GIRO account with HSA, licence renewal should be done online via PRISM as per current procedure. The auto-renewal scheme will appy prospectively to product licences due to expire 60 days from 15 April 2009 (i.e. 15 June 2009).

The submission of a CPP every two years is no longer a requisite for licence renewal, with effect from 15 April 2009. This requirement will be modified to a "as needed" basis, which means that HSA will request for a CPP in situations where it is deemed necessary for verification purposes. Product licence holders are reminded of their responsibilities under the Medicines (Licensing, Standard Provisions and Fees) Regulations to notify HSA of changes related to the manufacturing of a product and its registration status.

For product licence holders who have given an undertaking to submit a CPP to HSA prior to the implementation date, licence holders are expected to fulfil their undertaking as committed to the licensing authority. If a licence holder wishes to request for a waiver of this undertaking, such request should be submitted in writing to the Pharmaceuticals & Biologics Branch with details of the name and the product licence number of the medicinal product concerned.

For further enquiries and clarification, please contact Mr Thomas Koh at Tel: 68661055 or Email: Thomas_KOH@hsa.gov.sg. FAQ on the auto-renewal scheme will be available on HSA website shortly following this announcement.

 

1 November 2008 - Revised Poisons Licence Requirements for Retail Pharmacists - Rule 3 of the Poisons (Amendment) Rules 2008
 
The Health Sciences Authority has conducted a review of the Poisons Licence requirements for pharmacists practising in registered pharmacies. The following changes will be implemented from 1 November 2008:

• Pharmacists, who have valid practising certificates from the Singapore Pharmacy Council, are no longer required to hold Form C Poisons Licence to sell products containing scheduled poisons by retail in registered pharmacies.  

• Form A Poisons Licence will   still   be needed by pharmacists who are engaged in wholesale sale of scheduled poisons from registered pharmacies.

The Poisons Rules has been amended accordingly with the inclusion of a new Rule 14A.  

Retail pharmacists, who currently hold Form C Poisons Licence, may continue to deal in schedule poisons as allowed under the existing Form C Poisons Licence until the expiry of the licences. Pharmacists who wish to continue with wholesale sales of scheduled poisons (including export sales and supply to medical clinics and ships), are advised to apply for Form A Poisons Licence two weeks before the expiry of the existing Form C Poisons Licence. The application for Form A Poisons Licence can be made electronically from HSA website. 

For further clarifications if needed, please contact the Good Distribution Practice Unit at:
Tel: 68663518 or by e-mail at hsa_gdp@hsa.gov.sg

The Health Sciences Authority is pleased to introduce a new scheme for auto-renewal of product licences. In conjunction with the roll-out of this new initiative, HSA will also streamline the requirement for a Certificate for Pharmaceutical Product (CPP) for licence renewal.

 


       1 July 2006 - Movement Of Pharmacist(s) Among Various Pharmacy Outlets Registered Under The Same Company
    With effect from 1 July 2006, pharmacists who are rotated among the various pharmacy outlets registered under the same company are no longer required to submit any amendment application to their Form C Poisons Licences to effect such changes. However, this arrangement will not be applicable if the pharmacist is transferred to another outlet due to a closure of the pharmacy outlet where the pharmacist is licensed under.
       1 October 2005 - Display of Pharmacy Certificate
    With effect from 1 October 2005, all registered pharmacies are no longer required under the legislation to display the Certificate of Registration of Pharmacies at their operating premises.
       1 August 2005 - Reclassification of Zolpidem
    With effect from 1 August 2005, the drug Zolpidem will be removed from the First Schedule of the Misuse of Drugs Act (MDA) and the Second Schedule of the Misuse of Drugs Regulations (MDR).
       17 May 2005 - Transfer of Control of Acetyl chloride from HSA to the Singapore Civil Defence Force (SCDF)
    With effect from 1 June 2005, Acetyl chloride will be degazetted from the Poisons List and will not be controlled as poison. The legal control of Acetyl chloride will be transferred to SCDF. The amendment legislations are available for download.
       18 Feb 2005 - Guidance for Industry: Safety Reporting Requirements for Registered Medicinal Products
    This document is to guide licence holders on the submission of relevant safety information to the Centre of Drug Administration. It applies to licence holders who are responsible for introducing registered western medicinal products into Singapore.
       1 Feb 2005 - Revision of Drug Registration Guidelines on Minor Variation Applications
    The Centre for Drug Administration (CDA), HSA conducted a review of the minor variation guidelines. The revised guidance document is available for download.
       30 Jun 2004 - Legislative Changes and Implementation of Patent Linkage
    With effect from 1 July 2004, all product licence applicants are required to declare patent related information using the declaration form prescribed in Part I of the Sixth Schedule of the Medicines (Licensing, Standard Provisions and Fees) Regulations 2004.
Last updated on 30 Jun 2009 09:53:55