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

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Quality Assurance IssuesWHO Drug Information Vol. 25, No. 2, 2011• A Statement of Licensing Status ofPharmaceutical Product(s) (SLSPP);• Batch Certificate of a PharmaceuticalProduct (BCPP).Q17 By whom and when is a Certificatefor a Pharmaceutical Product (CPP)issued?A17 A CPP is issued by the competentauthority of the exporting country and isintended for use by the competent authorityof the importing country:• When a pharmaceutical product isunder consideration for a productlicence/marketing authorization forimportation and sale in the importingcountry.• When administrative action is requiredto renew, extend, vary or review suchlicence.Q18 When and by whom is a Statementof Licensing Status of PharmaceuticalProduct(s) (SLSPP) issued?A18 An SLSPP is issued by the competentauthority of the exporting country andis intended for use by importing agentswhen considering bids in an internationaltender. It is requested by the importingagent as a condition for bidding.Q19 What is a Batch Certificate?A19 A Batch Certificate accompanies andattests to the quality and expiry date of aspecific batch or consignment that hasalready been licensed/approved formarketing in the importing country.A batch certificate is usually issued by themanufacturer.In case of biological products, a lotcertificate is issued by the competentauthority of the exporting country.Q20 Is there a standard format forCPPs?A20 Yes, there is a standard format. TheWHO standard format was last agreed bythe World Health Assembly in 1997 (1).The standard WHO format for CPPsfacilitates understanding and review bythe recipient authority. It obliges certifyingauthorities to disclose important informationto the importing country.Recipient authorities should refrain fromobtaining data other than in the WHOstandard format or in addition to thestandard CPP format.Certifying authorities should not issue afree-sale certificate. This has beenreplaced by the WHO format CPP.Q21 Is the CPP evidence of quality,safety, efficacy review and approval?A21 Yes, the CPP is based on theassumption that the authorities issuing aCPP have the capacity to assess thequality, safety, and efficacy (QSE) of theproduct they have approved for marketing.Based on the intention of the Schemeand when evidence of approval in anothercountry is required, a recipientauthority may request a CPP if it isunable to undertake a full review of QSEdata.Q22 Does the CPP provide evidence ofgood manufacturing practices (GMP)status?A22 Yes. The GMP declaration in theCPP refers to assurance of GMP for theproduct approved in the certifying countryat the stated manufacturing site.In addition, certificates from medicinesregulatory authorities (MRAs) party to thePharmaceutical Inspection Cooperation116
WHO Drug Information Vol. 25, No. 2, 2011Quality Assurance IssuesScheme (PIC/S) and International Conferenceon Harmonisation (ICH) (USA,Japan, and EU) provide evidence of GMPstatus.Q23 What is the difference betweenapproval of the quality data in the submissionand evidence of GMP?A23 Approval of the quality information ina submission is a determination of howthe applicant proposes to manufactureand control the quality of the product atthe time of manufacture and throughoutthe life of the product.Evidence of GMP compliance confirmsthat the applicant company has been ableto demonstrate that the manufacturingfacilities and operations conform to goodmanufacturing practices (GMP) asrecommended by WHO.Q24 When would a CPP be required?A24 When the CPP replaces either a fullor partial quality, safety and efficacy(QSE) review. The CPP would be acondition of approval but it would not berequired at the time of submission.If local legislation stipulates provision of aCPP at the time of submission, theauthority review should comprise averification procedure with published,communicated timelines that should beshort and avoid delaying patient access.Q25 Are there any alternatives to a CPPas evidence of approval by an MRA?A25 In addition to the WHO CertificationScheme other forms of evidence include:• Product approval letters (or copies oflicences) from well-established MRAs,e.g., Australia, Canada, China, Denmark,Finland, Germany, India, Japan,Norway, Republic of Korea, Spain,United Kingdom, United States ofAmerica.• Positive scientific opinion from theEuropean Medicines Agency (EMA).• Decisions of the European Commission.• Licensing/approval information onregulatory authority web sites.• Evidence of approval on the UnitedStates Food and Drug Administrationweb site.Q26 Is it necessary for a pharmaceuticalproduct to be exported from the samecountry as the certifying authority?A26 No. It is not necessary for theproduct to be exported from the certifyingcountry as long as a declaration of GMPassurance appears on the CPP.The Scheme was established on thebasis that the certifying country was alsothe country where finished productmanufacture took place and was, therefore,the exporting country. Subsequentrevisions to the Scheme allow scope forCPPs to be issued by other referenceauthorities. Most certifying authoritiescurrently provide CPPs when the finishedproduct is not manufactured in the certifyingcountry on the basis of GMP assurance.Many authorities assume that certifyingauthorities issue CPPs even whenfinished product manufacture does notoccur in the certifying country. Strictadherence to the above assumptionpotentially limits licensing and registrationoptions and can delay the introduction oraffect the continued supply of neededmedicines.Q27 Is it possible to obtain a CPP from acertifying authority that is not of thecountry where the manufacture of thefinished product takes place?A27 Yes. The GMP declaration on theCPP will refer to assurance of GMP for117
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WHO Drug Information Vol. 25, No. 2, 2011

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