At Merck, we are committed to registering our medicines and vaccines in a timely fashion in markets where they are needed.
A major goal is to reduce the historic gap in product introduction between developed and developing countries. One way we strive to reach this goal is by prequalifying medicines and vaccines through the World Health Organization (WHO). WHO prequalification is required by UN agencies, which often procure healthcare products throughout developing countries in the absence of reliable national medicines authorities that would certify products for meeting required quality, safety and efficacy standards. As such, prequalification is an important step toward fostering global access.
- In order to facilitate institutional purchases of family planning products and provide quality assurance, Merck has sought WHO prequalification for EXLUTON® (lynestrenol oral contraceptive), IMPLANON® (etonogestrel implant) and MARVELON® (desogestrel - ethinyl estradiol)
- In May 2009, GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] was the first cervical cancer vaccine awarded WHO prequalification
- In October 2008, Merck announced that it had received WHO prequalification for ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)
- In December 2008, Merck received WHO prequalification for MMR-II® (Measles, Mumps, Rubella Virus Vaccine Live)
- In December 2008, our treatments for HIV/AIDS STOCRIN® (efavirenz), CRIXIVAN® (indinavir sulfate) and ATRIPLA® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) received WHO prequalification
- We are committed to work with the WHO for the prequalification of ISENTRESS® (raltegravir)
To increase the transparency of the company’s product registration status, we are disclosing registration information for ROTATEQ, GARDASIL and our four antiretrovirals (ARVs), and updating this information every six months. Click below for details:
Learn more about our commitment to register our: