The Pharmaceutical Society of Northern Ireland's Guide to Legal Requirements provides a reference to all pharmacists on the relevant legislation applying to the storage, labelling, sale and supply of medicinal products, poisons and chemicals*.

*Legislation is dynamic. Pharmacists are advised to take note of any relevant updates issued by the Pharmaceutical Society of Northern Ireland.

The full document can be accessed here.

Printed and hole-punched hard copies can be collected in person from the offices of the Pharmaceutical Society of Northern Ireland.

Alternatively, a copy can be posted if the office is provided with an addressed and stamped (£1.59 second class, £1.82 first class within the UK) A4 envelope.

For ease of online use, in the below sections, the guide has been divided into separate chapters.

Introduction and Glossary of Terms

An alphabetical list of common terms used throughout the guide.

 

 

 

 

 

1. Medicines for Human Use (pt 1): POM, P, GSL & General Pharmacy Regulations

This section of the Guide provides information on the legal requirements relating to General Sales List Medicines (GSL), Pharmacy Medicines (P), and Prescription Only Medicines (POM).

It also gives a brief description of some of the legislation pertaining to the Responsible Pharmacist requirements, Collection and Delivery services, and exemptions to medicines legislation that may come in to effect in the event of a pandemic or national health emergency.

 

 

 

2. Medicines for Human Use (pt 2): Controlled Drugs

A number of important changes to the legislation that applies to the management, supply and use of Controlled Drugs have been made in the period 2006 to 2010.

This section of the guide takes account of these, including the 2009 Accountable Officer regulations.

 

 

 

 

3. Medicines for Human Use (pt 3): Exemptions from the Controls on Retail Sale

In order to sell, supply, or administer medicines, people and/or organisations must first be able to obtain them. Registered pharmacies are thus one of the primary points for obtaining medicines.

This section of the guide outlines the manner in which pharmacists should conduct supply to hospitals, and various categories of practitioner and organisations to whom normal restrictions do not apply.

 

 

 

4. Medicines for Human Use (pt 4): Labelling, Advertising and Devices

This section of the Guide looks at the various labelling requirements required by law, according to the type of medicinal product.

The final sections cover: the advertising and promotion of medicines; medical devices; clinical trials; the use of Fluted Bottlesl; and, the sale and supply of Chloroform.

 

 

  

5. Medicines for Veterinary Use

This chapter explains the principal requirements of the Veterinary Medicines Regulations, on such matters as:   - the classification of Veterinary Medicinal Products (VMPs),
- handling of prescriptions for VMPs, and
- labelling and record keeping requirements.

 

 

 

6. Non-Medicinal Poisons

This section of the Guide looks at:
- the various schedules of non-medicinal poisons;
- the requirements around containers and labelling; and, 
- the requirements around storage and record keeping.

 

 

 

 

7. Denatured Alcohol

This chapter outlines:
- the types of denatured alcohol;
- the applications required to obtain denatured alcohol;
- user requirements for authorisation;
- record keeping regulations; and,
- criteria for distribution.

 

 

8. Chemicals

The final section of the Guide gives a summary of the principal requirements under the Chemical (Hazard Information and Packaging for Supply) Regulations.