Guide to South African Medicine registration numbers

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safety, efficacy or quality of the product no longer meets the required standards, the registration can be cancelled or withdrawn, e.g. Vioxx®.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”. 

Pharmacological classification 

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”. 

Other examples:

/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. 

Old medicine

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) 

Complementary medicines

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

24 Responses to Guide to South African Medicine registration numbers

  1. GCUMISA MBANGISENI GOLDEN 31 October, 2013 at 3:50 am #

    I have the medicine that remove menstrual cramps compete. I want to register my medicine what must i do.

  2. Harris 31 October, 2013 at 8:18 am #

    You need to contact the Medicines Control Council in Pretoria. http://www.doh.gov.za/show.php?id=2863
    See also: http://www.kznhealth.gov.za/research/mccinfo.pdf

  3. Carolyn 4 June, 2014 at 5:16 pm #

    Hi I do a 100% natural skin care range. We use only natural ingredients, no chemicals or preservative etc. Some of our balms aid in the healing wounds, rashes, eczema etc. None of the products are taken internally. They are only topical. First of all do we need to register our product and second of all how to we go about it. I have looked at all the info and it is mind blowing!! Is there a company in the Durban area that can give us a hand in helping with the registration etc.
    Thanks so much.

  4. TATOLI 17 January, 2015 at 8:04 am #

    HI
    We manufacture traditional/African medicines which cure painful menstruation, swollen feet, cough,
    I have been manufacturing these medication for the past 3years with positive result.
    what process must I follow to register them.

  5. daniel 19 February, 2015 at 3:23 pm #

    please kindly send the adress and as well the tellephone number for Medicine Control Coucil in Pretoria

  6. Rachel 16 September, 2015 at 4:50 pm #

    where or how can i find the 1986 gov.gazette 10430(no 1856) 12 september 1986. i need to find it ASAP.

  7. Joop 14 November, 2015 at 10:25 am #

    I’d like assistance with the official registration/approval of hair products for MCC, but I’d prefer not to contact CTFA, because they charge you R4000 annually if I am not mistaken. Who else can help me out?

    • Harris 15 November, 2015 at 7:07 am #

      @Joop
      There are a number of consultants who can help you. If you contact the MCC, they likely will supply you with a list of these.

  8. Joop 16 November, 2015 at 4:15 pm #

    I have been trying to get hold of the MCC, but nobody is answering the phone.

    Do you know a direct number and/or email address to fasten up the process?

    • Harris 16 November, 2015 at 4:29 pm #

      @Joop
      Unfortunately not. Have you tried via the Main Switchboard Dept of Health : 012 395 8000
      See http://www.mccza.com

  9. Zama 29 January, 2016 at 2:39 pm #

    Good Day

    I have an Indian nut for weight loss but requirements is MCC Certificate. Please advise

  10. Zydra 27 April, 2017 at 12:18 pm #

    Hi I am doing a expo on down-syndrome children and found an amazing medication that could help them on a cognitive level. But the medication is not in registrated South Africa. Where can I find a number that I can contact so that we can implement this medication?

  11. Modi Maqabaza 3 May, 2017 at 4:18 am #

    Please assist me as I want to register as a herbalist.

  12. Simone 22 June, 2017 at 12:24 pm #

    I need assistance and guidance on registering a ozone sauna device. MCC doesn’t respond to any of my voice mails or messages. How do I proceed?

    • Harris 22 June, 2017 at 12:43 pm #

      @Simone
      Unfortunately not. The alternative is to approach a company/consultant who assists with registration of products with the MCC.

  13. Tefo 8 September, 2017 at 7:02 pm #

    I have a herb that is very helpful with different problems. I was given the herb by my grandmother and it helped lot of people in the past, i want to sell this herb now as peoples use to get it free from my Granny. Please help on where to start

    • Harris 11 September, 2017 at 1:25 pm #

      @Tefo
      I suggest that you contact Rene Doms for his input – http://www.doms.co.za +27 825557621

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