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Complementary medicines come under scrutiny

As of 15 November 2013, new legislation has been passed which will bring complementary medicines under the same scrutiny as conventional medicines. Up until now, these medicines have - in terms of South African law - fallen beyond the scope of the Medicines and Related Substances Act 101 of 1965. The publication of the amended General Regulations relating to the Act has brought about fundamental changes in this regime and imposed more stringent conditions on manufacturers of these medicines.
Complementary medicines come under scrutiny
There are many of those who are still on the fence about complementary medicines. In essence, complementary medicines are alternative medicines that are used in conjunction with conventional medical treatment based on the belief that it complements the treatment. These medicines generally originate from plant, animal or mineral and claim to assist the innate healing power of the individual to mitigate, modify, alleviate or prevent illness or the symptoms thereof or abnormal physical or mental state. While there is no hard scientific evidence to support this, there are many who claim to have seen progress in the bettering of their conditions from these alternative remedies.

Whether a natural aid or placebo potion, complementary medicines will now require registration by the Medicines Control Council of South Africa (MCC) and will be scrutinised for safety, efficacy and quality. Timothy Beattie, GM of Pyrotec PackMedia - the marketing leading provider of innovative on-pack solutions, says: "This has direct implications for all manufacturers, distributors, importers and exporters of these products, as they will now require licences to conduct these activities. Labelling, packaging inserts and patient information leaflets will also have to adhere to the regulations, with this provision coming into force as from 15 February 2014."

With the more stringent new legislation, manufacturers will need to comply or potentially face harsh penalties. This includes supplying additional information now stipulated by law, directly with the pack.

One affordable and versatile option is Fix-a-Form - a leaflet-label that is able to include extensive amounts of information in the space of a standard label. This device has been specifically designed with the pharmaceutical and agrochemical markets in mind, due to legislation that requires manufacturers to include reams of information pertaining to a products composition, usage instructions, precautions etc.

"Another obvious benefit is that, unlike with packaging inserts of leaflets, Fix-a-Form remains with the product and cannot be misplaced - making repeated reference simple," explains Beattie.

"New laws are constantly being passed that aim to regulate and govern the production and distribution of medicines - ultimately for our own good. However, these changing requirements can often be a difficult thing for manufacturers to deal with, as they need to relook at how their product is presented. Fix-a-Form makes compliance with these laws simple - and without compromising the aesthetic of the packaging."

29 Jan 2014 14:51