WHO Drug Information Vol. 25, No. 2, 2011

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▼Quality Assurance IssuesWHO Drug Information Vol. 25, No. 2, 2011Figure 1. Question 33: contract manufacturingCompany Aproduces X in aEuropean country MProduct X isregistered in thatcountry▼Company A also contractmanufactures X incountry Z in AsiaCPP PRODUCTCountry Y in Africa▼▼ImportingA34 Yes. The CPP can also provideevidence of an administrative review andapproval (e.g., as certification of acceptabilityof a company name change, or fora name change of the owner of a manufacturingor production site) which oftenhappens in the context of companymergers and acquisitions.For administrative approvals that nowinvolve a QSE review, recipient authoritiesshould use alternatives to a CPP as apreferred and quicker option (see Question9).Issues related to manufacturing companyname change (administrative review) mayindeed create various practical difficultiesfor exporters–importers but are notassociated directly with safety/qualityconcerns and should be given lessprominence.Q35 Imagine a situation in which aproduct is authorized for marketing in thecountry of manufacture but is not actuallyavailable on the market. Can the competentauthority of the exporting countryissue a CPP to support export?A35 Yes, it can issue a CPP. What itshould do is explain why it is not on themarket. One reason for not being on themarket could be that the disease/healthproblem for which the product is indicatedmay not be prevalent in the country.Q36 Sometimes a country may wish toimport a special dosage form, strength orformulation of a certain known productand this particular product may not beregistered in the manufacturing country.Under such circumstances can theauthority of the exporting country issue aCPP?A36 Yes. It can issue a CPP but it shouldexplain on the certificate that the particularproduct is not authorized for marketingin the exporting country, that it has beenproduced based on the request of theimporting country and that manufacturingis in compliance with GMP.120
WHO Drug Information Vol. 25, No. 2, 2011Quality Assurance IssuesQ37 Is it necessary to legalize the CPP?A37 No. Legalization is not part of theWHO Scheme and it is not considered toprovide additional assurance of authenticity.Approval status in key referencecountries is currently available as publicinformation.Legalization should not be necessarysince an official governmental authority ofthe certifying country signs the CPP.Legalization delays availability of the CPPand thereby delays access to medicinesfor patients. If a recipient authority hasany doubts about the validity of a CPP itshould contact the certifying authoritydirectly.Q38 What should receiving countries doin case of any doubt about a CPP?A38 In case of any doubt, the competentauthorities of receiving countries shouldcommunicate directly with the authorizedbody that has issued the certificate orcontact WHO to clarify the matter.Q39 Are certifying authorities penalized ifthey issue CPPs, but do not meet WHOrequirements for self-certification andsubsequent issue of CPPs?A39 No. There is no penal system. WHOdoes not have the power to certify,inspect or penalize certifying authorities.Q40 What are the main problems encounteredin the application of theScheme?A40 A number of problems have beenreported during use of the Scheme, whichinclude:• Countries not party to the Scheme issuecertificates.• Authorities that do not meet the requirementsstated in the guidelines for theScheme issue certificates.• Some issuing authorities put the WHOemblem, logo or acronym on the certificate,thereby creating the impressionthat the certificate is authenticated byWHO.References1. WHO Certification Scheme on the Quality ofPharmaceutical Products Moving in InternationalCommerce. World Health Assemblyresolution WHA22.50 (1969), World HealthAssembly resolution WHA28.65 (1975), WorldHealth Assembly resolution WHA41.18 (1988),World Health Assembly resolution WHA45.29(1992), and World Health Assembly resolutionWHA50.3 (1997) available at: http://www.who.int/governance2. World Health Organization. Expert Committeeon Specifications for PharmaceuticalPreparations. Technical Report Series,2009;953:47-48 at http://www.who.int/medicines/publications.121
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WHO Drug Information Vol. 25, No. 2, 2011

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