The Pharmacy and Poisons (Amendment) Bill 2014 ("Bill") was introduced in March 2014. The Bill proposes substantial changes aimed at improving and updating the regulatory framework of the Pharmacy and Poisons Ordinance. If implemented, the new statutory provisions will impose several additional requirements on manufacturers and sellers of pharmaceutical products. We set out below the major changes proposed in the Bill.
New requirements proposed in the Bill
i. Manufacturing pharmaceutical products
- Principles and guidelines for manufacturing in compliance with the Good Manufacturing Practice Guide (GMP Guide) issued by the Pharmacy and Poisons Board will be introduced. Non-compliance with the GMP Guide may result in disciplinary action under the subsidiary regulations of the Pharmacy and Poisons Ordinance.
- Licensed manufacturers of pharmaceutical products will be required to employ at least one authorised person (AP) to ensure and certify that pharmaceutical products are manufactured and checked in accordance with the GMP Guide. Qualifications requirements and procedures for registration as an AP will be formulated and will include registered pharmacists and persons completing recognised courses by the Pharmacy and Poisons Board – both of which shall have a minimum of three years of experience relevant to the manufacturing or quality control of pharmaceutical products. A register of APs will be established.
- Licensed manufacturers will be required to ensure that the particulars of each completed batch of pharmaceutical products corresponds exactly with the products' registered particulars.
ii. Packaging and labelling
- Labelling requirements for pharmaceutical products will be expanded to include the product's batch number and expiry date in addition to the current requirements to include active constituents of the product, the name and address of the manufacturer, and the drug registration certificate number.
- Secondary packaging will only be allowed to be undertaken by licensed manufacturers who comply with GMP Guide requirements. Secondary packaging refers to packaging activities which do not expose the pharmaceuticals to air, for example, putting bottles of pharmaceutical products or strip-packed tablets into cartons, and labelling those bottles and cartons. This change will be effected by expanding the definition of "manufacture" to explicitly include secondary packaging.
- Pharmaceutical products will no longer be required to be labelled with the word "Poison" in red lettering. Instead, they will be required to be labelled "Prescription Drug" or "Drug under Supervised Sales" depending on the category of sale restriction they fall under. The purpose of this change in terminology is to avoid giving the impression that the labelled products are unsuitable for general consumption or use.
iii. Selling, importing and exporting
- A person who wishes to import or export pharmaceutical products must first obtain a wholesale dealer licence or a manufacturing licence. The wholesale dealer licence will replace the existing wholesale poisons licence.
- Authorised sellers of poisons will also be required to obtain a manufacturing licence.
- All products listed in Part I of the Poisons List kept at retail shops will be required to be stored in locked receptacles in areas inaccessible to customers. The keys to the locked receptacles must be kept by a registered pharmacist.
- Wholesale dealers and licensed manufacturers will be required to keep transaction records for all pharmaceutical product transactions, and not just transactions in respect of poisons listed in Part I of the Poisons List. They will be required to record additional particulars, such as the batch number and pack size.
iv. Clinical trials
- Clinical trials may only be conducted after obtaining a clinical trial certificate or medicinal test certificate. Contravention of this licensing requirement will constitute an offence.
- Conditions may be imposed on issuing a clinical trial certificate or medicinal test certificate. These certificates may be cancelled or suspended on the contravention of any of the imposed conditions, or on the ground of public interest.
- The maximum term of validity of these certificates will be extended from two to five years.
Current status of the Bill
Legislative Council members have generally been supportive of the new proposals. The First Reading of the Bill and commencement of the Second Reading Debate took place at the Legislative Council meeting on 26 March 2014. The Debate was adjourned and the Bill was referred to the Bills Committee for further discussion. The pharmacist sector expressed concerns that the qualification of non-pharmacists as APs under the Bill might weaken the quality control over the manufacturing process. It remains to be seen whether the Bill will be passed in the current legislative session.
Originally published June 2014.
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