ADVOKS GLOBAL · KENYA
The Breast Milk Substitutes (Regulation and Control) (General) Regulations
27. Creating awareness
Edition: 2022-12-31 · In force
27. Creating awareness
(1)Subject to section 6(3) of the Act, a manufacturer or distributor who wishes to create awareness about the scientific and factual matters of the breast milk substitute or complementary food product, shall before commencing interactions with any health worker apply in writing to the Committee for approval.(1A)The Committee shall, upon receiving an application under this regulation, consider the application and respond to the applicant within fourteen days from the day of making the decision.(2)An application made under subregulation (1), shall expressly provide for the following information—(a)a sworn statement that the interaction does not imply an endorsement of the designated product or pre-packaged complementary food;(b)a sworn statement that there is no existing relationship, collaboration or partnership or intended relationship, collaboration or partnership with the health worker;(c)particulars of the health workers targeted for awareness;(d)proposed public venue;(e)sample of the designated product or pre-packaged complementary food to be used during the interaction;(f)a certificate of analysis from a public analyst in Kenya;(g)a detailed report on scientific findings and evidence based research on the benefits of the product;(h)a peer-reviewed scientific information of the product;(i)proof that the designated product or pre-packaged complementary food to be used during the interaction meets the national and international standards; and(j)any other relevant document requested by the Committee.(3)An applicant who is required to supply additional information under paragraph (j), shall do so within a period of 30 days from the date of the request.