South african regulatory guidelines

South African Medicines and Medical Devices Regulatory Authority Act

Access to safe and affordable food is important to humans and animals. Food that carries potential risks can be harmful to health.

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Consumers expect and deserve protection against risks found in food and therefore appropriate regulatory systems are important. DAFF regulates safety and quality of agriculture and animal products in terms of several acts of parliament. This Act addresses the manufacture, labelling, sale and importation of foodstuffs.

Matters regarding the hygiene of foodstuffs are addressed by the National Health Act,and the hygiene requirements at ports and airports including vessels and aircraft are addressed by the International Health Regulations Act, Food legislation is based on the presumption of safety. Where a substance is not naturally present in a food e.

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The FCD Act is considered to be a reactive act which means that approved and acceptable sources are taken in to account to provide the information on safety of foodstuffs for regulatory purposes. Such sources include:. The abovementioned Acts are pro-active, which means that government approval must be obtained for the release of a product on the market. Assessments are required of the data and information submitted by the applicant to determine the risk.

These assessments are conducted by a group of independent experts or government officials trained to do so. The development of regulations under the FCD Act requires expert knowledge of a number of areas: microbiology, additives, mycotoxins, irradiation of food etc.

FLAG is comprised of academics, scientists, consumers and representatives of various industries and organizations.

It should be noted that the power to enforce the FCD Act is delegated to provincial and local health authorities. Government officials represent the country at the meetings of the committees where standards are developed on a consensus base. The government cannot protect consumers from the consequences of their own actions. Consumers need to take responsibility and strive to become informed and knowledgeable about food issues in order to make selective food purchases and practice the necessary safety requirements when handling, preparing and storing food.

Such sources include: Codex Alimentarius standards and guidelines The Fertilizers, Farm Feed, Agricultural Remedies and Stock Remedies Act, 26 ofwhich set out regulatory requirements for registration of pesticides and stock remedies The Medicines and Related Substances Control Act 65 ofwhich sets out regulatory requirements for registration of veterinary medicines The Genetically Modified Organisms Act 15 ofwhich sets out regulatory requirements for foods from genetically modified organisms The abovementioned Acts are pro-active, which means that government approval must be obtained for the release of a product on the market.

What Is The Codex Alimentarius? Articles are written by trained technical food and nutrition professionals who source information from respectable scientific sources throughout the world.

Information from FACS articles, identified as such in the article index, can be freely used on condition that the source is acknowledged.

The South African Regulatory System: Past, Present, and Future

See www. The FACS objective is to provide consumers with scientifically correct information on food and nutrition issues.Before you can bring goods into the country there are a plethora of regulations you need to get through. If you intend to ship goods through South African borders, you should know exactly what the current customs regulations are. Individual countries maintain control over what enters and exits their borders.

Every county has a list of restricted goods, although South Africa has relaxed a bit and recently decreased its list of restricted goods. The restricted goods that still require permits are fish products, petroleum products, ozone-depleting chemicals, firearms, gambling equipment and radioactive chemicals.

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These restrictions protect countries from danger, and in the case of South Africa, also protect her bordering countries. Along with the products that are obviously prohibited from importation into South Africa, such as drugs, pornography, diamonds and gold, are a number of prohibited foodstuffs. Anything related to bees such as honey or wax is prohibited, as is anything plant related such as bulbs, seeds, plants and raw cotton.

Second-hand goods, such as cars, are also not let through shipping customs. South Africa reformed its shipping tariff structure in to comply with international standards. The tariff system is a lot simpler than before and duties on goods range between 0 and 30 percent. Textiles tend to have higher tariffs and some goods have tariffs which exceed 30 percent. South Africa has had a free trade agreement with the EU sinceso tariffs are suspended for goods on the free tariff list.

Regulation of Food Safety and Quality in South Africa

Inautomotive products were added to the list but there were problems with implementing the free trade agreement for automobiles. Duties also need to be paid for alcoholic good and perfumes.

When shipping these products, they must be easy to access by customs officials and should be accompanied by a detailed list of what the containers hold. Owing to health reasons, the import of agricultural products is strictly controlled and many types of agricultural produce are denied entry into South Africa, particularly meat and fruit which can carry disease. There are restrictions on the importation of apples, cherries and pears, as well as irradiated or raw meat. Animals are also strictly monitored to avoid the transmission of disease over borders and to prevent the illegal animal trade, which is notorious for cruelty to animals.

Quarantining personal pets before entry into South Africa is sometimes compulsory, although it is dependent upon circumstances. Have a cookie Expatica uses technology such as cookies and scripts to personalize content and ads, provide social media features, and analyze our traffic.

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By using our website you agree to our use of cookies as set out in our Privacy Policy. Following the release of its position paper in Februarythe Independent Communications Authority of South Africa ICASA published its long-awaited draft regulations on ownership and control in the telecommunications and broadcasting sectors, for public comment, on Friday, 14 February The deadline for submissions on the draft regulations is 3 April It appears that this requirement may apply to both applicants for individual licences and registrants for class licences, although this is an area that requires clarification.

Currently under the Electronic Communications Act, ECAand following the High Court's decision in Telkom SA SOC Limited v Mncube NO inHDP ownership requirements only apply to individual licence applicants not class licence registrantsand where an individual licence is transferred, subject to a "transfer of control", amended or renewed; there is no ongoing obligation to maintain a particular level of ownership by HDPs.

As contemplated in ICASA's position paper, the draft regulations now propose to impose a minimum ownership requirement that will apply for the whole licence term.

The two separate proposed requirements in relation to ownership by HDPs, on the one hand, and ownership by Black people on the other hand, overlap significantly, given that Black people are HDPs.

The draft regulations also do not clearly address the application of the principles in the ICT Sector Code when a licensee determines its percentage Black ownership for the purposes of the regulations.

The regulations will also have significant implications for corporate activity in the communications sector. Currently the requirement under the ECA is only that individual licensees must get ICASA's prior consent to transfer control of an individual licence, where control is not defined. As the approval process can be lengthy, this could result in significant delays in completing transactions in the communications sector.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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According to Additional Resource Cthis agency is responsible for ensuring that all clinical trials of both non-registered medicines and new indications of registered medicines comply with the essential requirements for safety, quality, and efficacy. When fully established, SAHPRA will conduct the monitoring, evaluation, regulation, investigation, inspection, registration, and control of clinical trials.

south african regulatory guidelines

Among other functions, SAHPRA will ensure that clinical trial protocols are being assessed according to prescribed ethical and professional criteria and standards.

Applicants will interact with portfolio coordinators, whose roles will be to steer applications through the prescribed processes. Per Additional Resource Gexpert committees, including the Clinical Trials Committee, will continue to provide scientific expertise and support.

Protocol Amendments during Conduct of Clinical Trials: ctcamendments sahpra. Bioequivalence Studies: ctcbeprotocols sahpra. Notifications and Notification Studies: ctcnotifications sahpra. Individual Serious Adverse Events: ctcsaes sahpra. Pharmacovigilance Contact: Florah Matlala Phone: For General Enquiries: enquiries sahpra. Clinical Trial Review Process. The CTC committee, in turn, considers the scientific, medical, and ethical issues of the applications, and ensures that the submissions provide proof of safety, quality, and efficacy of the investigational product for both unregistered and registered medicines.

See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements. The G-CTA also provides the following list of questions to guide the committee in its review process:. Per the G-CapacitySAHPRA will also review clinical trial applications for evidence and activity plans to build capacity at each study site as well as enhancing research activities and skills of professionals from historically disadvantaged groups.

See G-Capacity for detailed information on actions that will comply with this requirement. As delineated in the G-GenInfo and the MRSA-Feesapplicants are responsible for paying several non-refundable fees to submit a clinical trial application. The various fee types include the following:. Check payments should not be made. As soon as the deposit has been made, email a confirmation of such deposit to naazneed. This confirmation must also clearly indicate the reference for the deposit—screening fee for application number xxxxx, as well as a deposit reference number.

If payments for more than one 1 item are made per transaction, a clear breakdown must be supplied with the proof of payment. In the reference field, preference should be given to the telephone number if space is an issue. South Africa has a centralized registration process for ethics committees ECs.

NHREC gives direction on ethical issues relating to health and develops guidelines for the conduct of research involving humans and animals. Further, NHREC observes and advises on international developments in health ethics issues with relevant international organizations. Section 73 of the NHA requires that every institution, health agency, and health establishment at which research is conducted establish an EC or have access to an independent EC.

Please refer to Authorizing Body subtopic for additional information. As delineated in the SA-GCPs and the G-EthicsHRan EC must consist of members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of all proposed research studies. In addition to complying with composition requirements, an institution or organization must select EC members according to prescribed recruitment and appointment procedures.

As stated in the SA-GCPs and the G-EthicsHRmembers must receive a formal notice of appointment and assurance that they will be legally protected with respect to any liabilities that may arise during their term.

Role in Clinical Trial Approval Process. Please see Additional Resource C for detailed information on issues that the EC should consider when reviewing a proposed study. This will be done either by email or fax and will be sent to both the relevant EC s and the PI or the sponsor. Receipt of the SANCTR number provides the research team with the authority to commence the study pending the approval of other relevant clearances, such as provincial and hospital approvals. See Additional Resources A and B for detailed registration instructions.

Per Additional Resource Dif there is an amendment to the protocol, the sponsor must notify the EC and get its approval. Although South African ECs may decide on their own whether to charge a research review fee, ECs typically only charge to review research funded outside of the institution or industry-sponsored research.Are you encountering difficulty in applying for a licence for medicinal cannabis? She will also discuss which products are legal to manufacture, sell, purchase, possess and consume.

See more. SAHPRA is tasked with regulating monitoring, evaluating, investigating, inspecting and registering all health products and clinical trials in South Africa. Read latest updates. Codeine-containing medicines. More Information. Safety alerts. May MSA Rotarix. March MSA promethazine. The Medicines Control Council MCC alerts all health care professionals to new prescribing information for promethazine.

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September More Alerts. Lethyl 30 mg Aspen Pharmacare Recall Letter. This recall is initiated as a result of product quality complaint logged with Aspen Pharmacare due to the discloration of Lethyl 30 mg tablets.

Bioplus AdcockIngram Recall Letter. Following a customer complaint, we have identified the vitamin premix used in the manufacture of the affected product and batches contain additional vitamins and minerals. October 25, More Products. The annual report has been prepared in accordance with the guidelines on the annual report as issued by the National Treasury. Cannabis and related substances A5 final.

Registrations of Medicines. October Fees payable in terms of the provisions of the medicines and related substances act, Workshops and Conferences. Assessing similarity of biosimilars. In South Africa, potential manufacturers of biosimilars lack a roadmap for comparing….

DC formulation and delivery. Immunogenicity of biopharmaceuticals. What are biotechnology products? View on facebook. Reply on Twitter Retweet on Twitter 48 Like on Twitter Twitter The issue of business compliance may be a touchy one for most South African business owners, with many feeling that there is too much red tape.

If you have registered a company, be sure to register it with SARS, in addition to registering yourself as a taxpayer. If you have employees, you must remember to deduct tax from them and pay it to SARS each month. Also, you must collect and pay VAT if your business has an annual turnover in excess of R1 million.

As an employer, familiarise yourself with the Basic Conditions of Employment Act. This law governs relationships between companies and employees, setting out rules around working hours, overtime, leave, and the processes that need to be followed should you need to dismiss an employee. The Occupational Health and Safety Act gives workers a range of rights in terms of health and safety in the workplace. Regulations in the Act provide guidelines around aspects of workplace safety such as first aid, protective clothing, machinery, ladders, firefighting equipment, ventilation, lighting, temperature, noise and asbestos.

Municipal bylaws, governing zoning, noise levels, hygiene, and so forth will also have impact on your business. For example, you will probably need permissions to run a noisy manufacturing operation or a night club in a quiet suburban street, and should you wish to renovate your office building you may also need permission for that. With laws such as the Consumer Protection Act, government and regulators are becoming more stringent about consumer rights in South Africa.

You should investigate what these laws have to say about how you should advertise your goods, structure your contracts with consumers, handle customer data, deal with merchandise returns under warranty, and so on. Sign up to our Newsletter and receive info on Funding and Business Opportunities!

You can find her at lelele3. Facebook Comments. Related posts. Want More?Medical Device Definition. A medical device means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent a used or purporting to be suitable for use or manufactured or sold for use in -i the diagnosis, treatment, mitigation, modification, monitoring or prevention of disease, abnormal physical or mental states or the symptoms thereof; or ii restoring, correcting or modifying any somatic or psychic or organic function; or iii the diagnosis or prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological or metabolic means in or on the human body but which may be assisted in its function by such means; or b declared by the Minister by notice in the Gazette to be a medical device, and includes any part or an accessory of a medical device.

Classification of Medical Device. Classification Examples Risk Level A Absorbent pads, syringes without needles, non-sterile dressings Low B Adhesives for topical use, oxygen tubing and masks, bridges and crown Moderate-Low C Tubes for blood transfusion, urethral stents, intravenous cannulae Moderate-High D Cardiovascular catheters, angioplasty balloon catheters, pacemakers High.

Premarket Approval Process.

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AR submits application to the Council. Medical device will be included in the Medical Device register. Additional Information.

south african regulatory guidelines

Validity Licence issued is valid until guideline is revised. Postmarket Surveillance Implement necessary corrective actions. Report adverse events and device recalls. Language ALl documents should be submitted in English Recent Updates Domestic manufacturers and distributors must register by August Domestic wholesalers must register by February Need More Information.

south african regulatory guidelines

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