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CTD Conversion

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African Common Technical Document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.

From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

Freyr is currently working with many Global Pharmaceutical and Consumer Health Care companies in supporting them in planning and executing the CTD conversion requirement for the existing and new product registrations in South Africa enabling them to meet the MCC mandate.  For some of these global companies CTD conversion is a time consuming and a huge responsibility that needs careful planning and execution given their growing product portfolio in the African market.

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Good Manufacturing Practice

Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards.

  • Regular periodic or rolling quality reviews of all registered medicinal products, including export only products are conducted.
  • The Manufacturer and Holder of Certificate of Registration, where different, should evaluate the results of the review and an assessment should be made of whether corrective and preventative action or any revalidation should be undertaken.

Medicines Control Council’s (MCC)  general policy is that the standard to be used to assess compliance with current Good Manufacturing Practice (cGMP), is the South African Guide to Good Manufacturing Practice (SA guide to GMP).

  • Under Section 22C of the Act, all South African manufacturers should be licensed
  • The Act requires that overseas manufacturers of medicine supplied to South Africa should comply with the same or equivalent manufacturing standards as expected of South African manufacturers
  • When acceptable evidence of GMP compliance is not available, overseas manufacturers are inspected by the GMP Inspectorate before registration of the medicine is approved

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Medicines Registration

Medicines to be used in South Africa for both public and private sectors shall be duly registered with the national regulatory authority, the Medicines Control Council’s (MCC) in accordance with the provisions and requirements of the Medicines and Related Substances Control Act No. 101 of 1965 and the Regulations and Guidelines published in terms thereof.

A written notification from the Minister to the effect that the medicine is considered essential to national health; an expert report (which is not more than 2 (two) years old; a package insert (where the product has been approved) and a summary basis for the registration (SBRA) should be submitted with application.

The Registrar shall notify the applicant within 30 days of the date of receipt of the application and the Council shall, within 9 months make a decision with regard to the application.

The abbreviated medicine review process is based mainly on the expert reports of the pharmaco toxicological and clinical data.

Applications for Abbreviated Medicine Review Process (AMRP) can only be accepted if the product has been approved by the said authorities within the last three years of the license in the licensing country.

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Submissions Publishing

In June 2010, The Medicines Control Council (MCC) announced the intention to implement the South African common technical document (ZA CTD) format which will replace the current MRF1 and any applications still in MBR1 format.  From June 2011, submissions in ZA CTD format are mandatory (excluding veterinary medicines).

With the need for converting old format submissions to CTD format comes the opportunity for Market Authorization Holders (MAH) to plan and be ready for electronic submissions.  Freyr can compile submissions in eCTD format and print in paper format as required by the current MCC requirement. This allows the MAHs to be prepared for future eCTD requirements from MCC and enables efficient electronic submission dossier management.

Registrations and Submissions Information Management

Module 1 (Administrative 1.10 Foreign Regulatory Status) requirement from Medicines Control Council’s (MCC) requires the applicant to provide a list of countries in which an application for the same product is being applied for in South Africa has been submitted, dates of submission (if available). This should detail approvals (with indications).  Applicants must declare whether a marketing application for the medicine has been rejected in the countries listed under 1.10.1 prior to submission of the application in South Africa. If the medicine has been rejected, repeatedly deferred or withdrawn, then the MCC must be informed and the reasons supplied.

If no application has been submitted for registration in the country of origin, include a statement to provide the reason for this decision. It should be noted that aforementioned information is required to be provided in dossier however, it does not mean that this will help to speed up the review process.

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Brexit

  1. Home
  2. Brexit
  • The Regulatory Maze: A Roadmap for Placing Your Medical Device on the EU, UK, and Switzerland Markets

    November 07, 2023
    Medical Devices
    The Regulatory Maze: A Roadmap for Placing Your Medical Device on the EU, UK, and Switzerland Markets

    The European medical devices market, being the second largest in the world, is majorly driven by a growing patient population, technological advancements, and increasing healthcare expenditure. However, when it comes to expanding the medical device business into the European geography, a complex web of regulations and recent geopolitical changes adds an extra layer of challenge.

    • Read more about The Regulatory Maze: A Roadmap for Placing Your Medical Device on the EU, UK, and Switzerland Markets
  • Medical Devices in the UK & UKCA Certification Readiness – Get Insights in this Webinar

    May 05, 2022
    Medical Devices
    Medical Devices in the UK & UKCA Certification Readiness – Get Insights in this Webinar

    Europe is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes. The UKCA mark came into effect on January 1, 2021, and the CE marked devices have a grace period until July 31, 2023, to eventually transition to the UKCA mark.

    • Read more about Medical Devices in the UK & UKCA Certification Readiness – Get Insights in this Webinar
  • Preventing Disruption of Medicines Supply Post-Brexit EC’s Plans for Northern Ireland

    February 17, 2022
    Pharmaceuticals
    Market Access
    Preventing Disruption of Medicines Supply Post-Brexit  EC’s Plans for Northern Ireland

    Based on the European Commission’s (EC) proposal on facilitating the movement of goods from Great Britain to Northern Ireland in October 2021, the Commission has now set up plans to maintain the medicines’ supply in specific markets post-Brexit.

    • Read more about Preventing Disruption of Medicines Supply Post-Brexit EC’s Plans for Northern Ireland
  • Brexit and Cosmetics Regulations: What are the Changes?

    September 02, 2021
    Cosmetics Regulatory Services
    Regulatory Affairs
    Brexit and Cosmetics Regulations: What are the Changes?

    Brexit has brought about significant changes in the EU and the UK in terms of regulations affiliated with cosmetics, pharmaceuticals, personal care products and medical devices. The UK decided to leave the EU in 2016 and officially left the trading bloc on Jan 31, 2020. Both countries decided to keep a few things unaltered until Dec 31, 2020.

    Significant Changes taken place in the Cosmetics Industry in the UK 2021

    Some significant changes have taken place in the UK post-Brexit, which are listed below.

    • Read more about Brexit and Cosmetics Regulations: What are the Changes?
  • GB BPR Transition Period and Deadlines

    May 11, 2021
    Chemicals
    Regulatory Affairs
    GB BPR Transition Period and Deadlines

    Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.

    Here are a few updates on the GB BPR:

    Table 1 

    Authorization

    • Read more about GB BPR Transition Period and Deadlines
  • What Does Brexit Mean for EU and UK Regulatory Submissions?

    May 11, 2021
    Regulatory Affairs
    Publishing & Submissions
    What Does Brexit Mean for EU and UK Regulatory Submissions?

    The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc. Let us have a look at what Brexit means for the EU and the UK Regulatory Submissions. Here is a clear-cut Brexit impact summary that has recently been published by a consulting firm.

    • Read more about What Does Brexit Mean for EU and UK Regulatory Submissions?
  • Post-Brexit Labeling Updates for Food Products in the UK

    February 05, 2021
    Food and Food Supplements
    Regulatory Labeling
    Post-Brexit Labeling Updates for Food Products in the UK

    As you may know, January 1, 2021, has called off the 11-month long post-Brexit transition period. This also marked the deadline for the United Kingdom (UK) based food and beverages manufacturers to implement their product labeling changes. With regards to the changes, on November 5, 2020, the UK Department for Environment, Food & Rural Affairs (Defra) has published an update related to the information to be mentioned on the label of food products that are intended for sale in the UK and the European Union (EU), particularly in Northern Ireland.

    • Read more about Post-Brexit Labeling Updates for Food Products in the UK
  • Potential Impact of Brexit on Chemical Industry

    February 05, 2021
    Chemicals
    Regulatory Affairs
    Potential Impact of Brexit on Chemical Industry

    Being one of the crucial export sectors of the UK, the Chemicals industry could get hit hard due to Brexit. British companies are already competing with the American and the Asian markets and are under tremendous pressure in battling higher R&D costs.

    • Read more about Potential Impact of Brexit on Chemical Industry
  • Role of MHRA and Post-Brexit Scenario for Medical Devices in the UK

    October 13, 2020
    Medical Devices
    Role of MHRA and Post-Brexit Scenario for Medical Devices in the UK

    Since the commencement of Brexit transition timelines, the entire medical devices community is underway to understand its impact on future trade and Regulatory relations between the European Union (EU) and the United Kingdom (UK). As noted, the UK left the EU on January 31, 2020, as per the Withdrawal Agreement between both the countries. The agreement brings up a transition period until December 31, 2020, which intends to give time for national administrations, businesses and citizens to get ready for the significant changes due to the Brexit.

    • Read more about Role of MHRA and Post-Brexit Scenario for Medical Devices in the UK
  • Brexit-related Guidance for Pharmaceutical Companies

    October 08, 2020
    Pharmaceuticals
    Regulatory Affairs
    Brexit-related Guidance for Pharmaceutical Companies

    It is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law. In March 2020, EMA also updated Brexit-related guidance for the benefit of the pharmaceutical companies. As per the guidance, the following entities can be located in the UK until the year-end:

    • Read more about Brexit-related Guidance for Pharmaceutical Companies

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Publishing and Submissions
Regulatory Labeling

Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.

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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.

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The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.

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