Medicine registration numbers
Author: Miranda Viljoen, Director: SAAPI
The thalidomide tragedy in the early 1960s prompted authorities to introduce an evaluation system globally whereby the safety, efficacy and quality of any new medicine had to be assessed and approved before the medicine, including complementary medicines, was marketed. Prior to this, there was no formal system of medicine registration and any new preparation could be introduced onto the market without the manufacturer having carried out preclinical and clinical testing, and without having had the manufacturing materials and procedures regulated and approved.
In South Africa, the regulation of medicines was introduced in 1965 by the promulgation of Act 101. The act stipulated that all medicines had to be approved and registered by the Medicines Control Council (MCC) before being marketed. Once the product was approved, a unique registration number would be allocated to the product. This number therefore indicates that the safety, efficacy and quality of the product have been evaluated and approved. This unique number is allocated to the product for the duration of its lifecycle and if, at any stage, it can be shown that the risk/benefit ratio of the product has changed [e.g. good manufacturing practice (GMP) status of the manufacturer, or results of pharmacovigilance data], and the safety, efficacy or quality of the product no longer meets the required standards, the registration can be cancelled or withdrawn, e.g. Vioxx®. The registration number is therefore an extremely important piece of information, and Act 101, as amended, stipulates that this number must appear on the label, carton, package insert and advertising material of the product.
Year of application for registration
The first letter or digit indicates the year in which application for registration of the product was submitted to the MCC, not necessarily the year in which it was registered. The registration numbers can have one of two formats.
For example, A/7.1.4/123 or 44/7.1.5/345
All the products submitted in 1965 were allocated the letter “A”.
After 26 years, when the letters of the alphabet had been exhausted, it was decided that in the years to come, numbers should be used, instead of letters. It was also decided to start with the number “27”
(following the 26 letters of the alphabet). Therefore, applications submitted in 2009, 44 years later, were allocated the number “44”.
The numbers between the two slashes indicate the pharmacological classification of the product, i.e. they describe what sort of product it is. For example, A/7.1.4/123 or 44/7.1.5/345
All products with “7.1.4” between the two slashes are, according to Regulation 25 of the Act, “Vasodilators:
coronary and other medicines used in angina pectoris”, and “7.1.5” are “Vasodilators: peripheral”.
/15.1/ Ophthalmic preparations with antibiotics and/or sulphonamides /15.2/ Ophthalmic preparations with corticosteroids
Number of application
The last number, e.g. 123 in A/7.1.4/123, indicates that the product is the 123rd application received by MCC in the year “A”, i.e. 1965.
The number 345 in 44/7.1.5/345 indicates that the product is the 345th application received by the MCC in the year “44”, i.e. 2009.
If a medicine has a “reference number” instead of a “registration number”, it means that this is an “old medicine” which was on the market before the promulgation of Act 101 in 1965. An application for registration has been submitted, and in terms of Section 14 of the Act, the product may be sold, but it has never had a full evaluation and approval for registration. The reference number allocated by the Registrar to such an application is a letter and a number followed by the words “Act 101/1965”. For example, G3124 (Act 101/1965)
Most complementary medicines have never been submitted to MCC for application for registration. In 2002, the MCC instituted a system for complementary medicines. Applicants were required to submit basic information regarding the medicine and MCC allocated a “complementary registry number” to the products submitted. These medicines have not been evaluated for safety, efficacy and quality, and are not registered, but are merely listed in a registry. An example of a complementary medicines registry number is “135626”. This number was allocated to a complementary medicine submitted to the MCC in 2009, for inclusion in the registry.
Extracted from: SA Association of Pharmacists in the Industry S Afr Pharm J 48 2011 Vol 78 No 2
Thanks to Andy Gray for highlighting this article