Guidelines for registration of a new Drug in Kenya.

Guidelines registration new drug Kenya
guidelines registration new drug Kenya

1.Two dully filled application forms (Original and Duplicate) and an electronic copy (a summary of the dossier contents) in MS Word on a CD-ROM of modules 1 and 2 only including their supporting documents –

ii. Three (3) samples of the smallest commercial pack(s) from one batch with batch certificates of analysis

iii. An original Certificate of Pharmaceutical Product (WHO Format) on official papers of the issuing competent drug regulatory authority.

iv. A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.

v. Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not yet inspected by PPB.

Applications for Renewal of Registration Applications for renewal of registration shall be made at least 3 months before the expiry of existing registration by submitting the following:
i. Dully filled in application form for renewal of registration.

ii. Batch Manufacturing Record (BMR) of a real batch manufactured within at most six months before the submission of the application.

iii. Submit Periodic Safety Update Reports (PSUR)

iv. Proof of interchangeability for generics as explained in Module 5.

v. Any other requirements that the Board may determine.

vi. Three (3) samples of the smallest commercial pack(s) from the same batch along with batch certificates of analysis.

vii. A site master file in case the product is manufactured at a plant(s) not inspected and approved by PPB.

viii. Non refundable application fee for registration of medicines in Kenya and GMP inspection fees for facilities not inspected and approved by PPB, GMP department.

Application for Variation of a registered medicinal product All applications for variation to a registered product shall be made according to requirements stipulated in the PPB Application Guideline for Variation of Registered Medicinal Products also available the PPB offices.

For more information click here PPB

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