March 12, 2017

New Rules for Importation of Pharmaceutical Products

The Minister of Health issued Decree no. 5 of 2017 announcing some additional rules for importing drugs, raw materials, vaccines, baby milk and medical supplies from reference and non-reference countries.

For drugs and its raw materials, importation shall be from counties which apply
international monitoring standards and have efficient supervisory authorities which are
accredited by international organization specially the WHO WFO, EMA, and FDA.
Importation from non-reference counties can be allowed provided that the
manufacturing companies must be following the Good Manufacturing Practices for
Pharmaceutical Products (GMP) approved by international organization such as WHO,
WFO, EMA, and FDA, or its products are traded in a reference country.

For vaccines, genetic engineering materials and extracts, the international
registration rules will be followed whether the importation is from a reference or
non-refence country according to the ICH GHIDLINES standard.

For baby milk, importation will be from referenced countries applying international
standards, or non-referenced countries in case the imported product is traded in a
reference country.

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