PROTECTING YOUR RIGHT TO MEDICINES AND MEDICAL DEVICES
Monday, 27 January 2020

2019 Bulletin Picture.

Inside this issue:

  1. E-Reporting Tools
  2. Safety Notifications for Fluoroquinolones and Quinolones Antibiotics
  3. Notification of a potential risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) in patients treated with hydrochlorothiazide
  4. DTG and Neural tube defects
  5. Dangers of buying medicines from the streets and the role of MCAZ

Click here to download the 2019 Medicines Information Bulletin

Code of Ethics Picture.

 

In pursuit of promoting high ethical standards, the Authority has formulated a Code of Ethics for its employees and members of the Authority .The Authority believes that high ethical standards are essential in enhancing corporate performance  and accountability ,ensuring  transparency and protecting stakeholders’ interests at all times.

To download the Code of Ethics click here.

 

 

MCAZ Draft Variation Guidelines.

In line with the WHO guidelines on variations and other SRA guidelines, the EVR Division is updating the MCAZ Guidelines for submitting applications for Variations to Registered Medicines.
The update is to ensure; inclusion of the classification of additional post-registration changes and to establish the level of risk inherent to each change, definition of timelines for different types of variations, alignment of variation submissions with the CTD format, inclusion of requirements for variations for sterile and biological products and inclusion of requirements and timelines for SRA and WHO PQ approved products variations.
Applicants should make use of the attached template EVR form 38 i.e. Comments to draft Guidelines for submitting applications for Variations to Registered Medicines. The duly completed form should be emailed to This email address is being protected from spambots. You need JavaScript enabled to view it. by no later than 15 July 2019.
 
 

 

 

SADC Pic.

 

Southern African Development Community (SADC), as a region has harmonized medicines registration guidelines in the common technical document (CTD) format that were approved in January 2015. Nevertheless, the harmonization of product information and labelling requirements within the region has been outstanding. Harmonizing regulatory standards to create one regional market and mutual recognition is one of the strategies included in the draft Strategy on Regional Manufacturing of Essential Medicines and Health Commodities (2016-2020), which supports the pharmaceutical component in the SADC Industrialization Strategy and Roadmap 2015 – 2063. Moreover, this supports the priority areas of creating an enabling regulatory environment and strengthening medicines regulatory capacity in the approved SADC Pharmaceutical Business Plan 2015 – 2019.
 
Taking into account the need for stakeholder engagement in drafting regulatory guidelines, a workshop with industry and regulators was held as the initial step in developing a regional guideline on product information and labelling. This engagement resulted in drafting instructions for the product information and labelling guideline that were approved by the regulators forum. Subsequently, these drafting instructions were utilized for formulating the guidelines presented in this document. Please Click the following links to download the Guidelines and Table for Comments.

SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING

SADC GUIDELINE ON PRODUCT INFORMATION AND LABELING: TABLE FOR COMMENTS

There are currently no vacancies...

 

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Inside this issue: E-Reporting Tools Safety Notifications for Fluoroquinolones and Quinolones Antibiotics Notification of a potential risk of non-melanoma skin cancer (basal cell carcinoma, squamous cell carcinoma) in patients treated...

Code of Ethics

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