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Chambers Global Practice Guide: Life Sciences 2020
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Latest Firm's PressShearn Delamore & Co.
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:
The main regulatory bodies for pharmaceuticals and medical devices are the:
All of the above legislation and regulatory bodies are under the purview of the Malaysian Ministry of Health (MOH). Challenging Decisions of Regulatory Bodies Appeals may be made against the decisions of the regulatory bodies in accordance with the procedure set out in the applicable Act or Regulations. Under Regulation 18, CDCR 1984:
Nevertheless, a person who is adversely affected by a decision, action or omission in relation to the exercise of a public duty or function shall also be entitled to make an application to the court for judicial review, pursuant to Order 53 of the Rules of Court 2012. The remedies which may be sought under the judicial review application are:
Pharmaceutical products are categorised into:
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