Cabinet of Ministers Regulation No
Cabinet ofMinisters Regulation No. 873
Riga, 17th September 2013 (prot. No.49, 58§)
StateAgency ofMedicines Publicly Available Paid ServicePriceList
Issued in accordancewith Article 5, Paragraph 1 of theLaw on PublicAgencies
1.ThisRegulationshalldeterminethepricelistofpaidservicesprovidedby theState
Agencyof Medicines (hereinafter-pricelist) andthe procedurefor payment.
2.TheStateAgency ofMedicinesshallprovidepaidservicesinaccordancewiththe pricelist (Annex).
3.Basing onanapplicationfromthemarketingauthorisationholderthe StateAgency of Medicinesshallhavetherighttoadopta decisionregardingexemptionfromthe annualpost-authorisationmaintenance fee for medicinalproducts,ifthe following requirementshavebeen fulfilled:
3.1.therealisationpriceofmedicinalproductisdeclaredintheStateAgency of Medicines in accordance with the normative acts regarding the principles for formation of prices of medicinal products;
3.2.themedicinalproductisdistributedin Latvia,buttheturnoverintheprevious calendaryear does notexceed 2134.31euro;
3.3.themarketingauthorisationholderhasreportedtotheStateAgency ofMedicines the actual date of thebeginningof distribution (marketing) of themedicinal product in Latviaorhasreportedthemedicinalproductsthatare (temporarilyorpermanently)no longer marketed inLatvia inaccordance withthe normative actsregardingprocedure fordistribution ofmedicinal products.
4. Thepayment forservices provided shallbemadein one ofthe followingways:
4.1. at theStateAgencyofMedicines byusingapayment card;
4.2.atacreditinstitutionor another finance institutionthatisentitledtoperform financial transactions.
5.The servicereceiver shallmake advancepaymentinfullamountfortheservices mentionedinSection1, 2,3,4,5,6,7,8,9,10,11and13oftheAnnexofthis Regulation byusinganon- cash transaction.
6. When submitting the documents necessaryfor receiving services to the State Agency ofMedicines,thesubmittershallsupplyoneofthefollowingdocuments verifyingthe transaction:
6.1.apaymentorderverifiedby thecreditinstitutionoraprintoutofthepayment madeviaonlinebankingofthecreditinstitutionverifying thattheadvancepayment mentionedinArticle5ofthisRegulationhasbeenmade(the nameofthepayeris clearlyindicated in thepayment printout and it is signed bythe payer);
6.2. a check issued bythe cash department of the StateAgencyof Medicines verifying anon-cash transaction with a payment card.
7. Theserviceprovision:
7.1.shallbeinitiatedafterreceiving thepaymentverifying documentmentionedin Article 6 of thisRegulation and after thetransaction of theappropriatesuminthe paymentaccount of theStateAgencyof Medicines;
7.2. maybediscontinued:
7.2.1. if theState AgencyofMedicines has adoptedtheappropriate decision in accordance withSection31of thePharmaceuticalLawandnormativeactsregarding procedure for marketing authorisation of medicinal products;
7.2.2.ifthe StateAgency ofMedicines hasreceivedanapplicationdeclining services from theservice receiver.
8.Whendiscontinuingtheprovisionofaservicethe StateAgency ofMedicinesshall chargeafeefor theservicesprovideduntilthediscontinuationofserviceprovision fromtheadvancepaymentmentionedin Article5ofthis Regulationin accordance with the followingprocedure:
8.1.ifprimary expertiseoftheapplicationhasbeencarriedoutdetermining the complianceofthemarketing authorisationandrenewalapplicationwiththe requirementsofthenormativeactsdetermining procedureformarketingauthorisation ofmedicinal products-10 percent of the feestated.
8.2.ifprimary expertiseoftheapplicationhasbeencarriedoutdetermining the complianceofthemarketing authorisationandrenewalapplicationwiththe requirementsofthenormativeactsdetermining procedureformarketingauthorisation of medicinalproductsandif the evaluationof theadditionaldata anddocumentation (expertiseondocumentation)regarding theservicesmentionedinSection1,2,3,4,5,
6, 7, 8, 9, 10, 11 and 13 of theAnnexof this Regulation has been initiated-50 percent ofthe feestated.
8.3. if the evaluationof the additional dataand documentation (expertise on documentation) regardingtheservices mentionedin Section 1, 2, 3,4, 5, 6,7, 8, 9,10,
11and13ofthe AnnexofthisRegulationhasbeencarriedout-90percentofthefee stated.
9.InthecasesmentionedinArticle8ofthisRegulationtheStateAgency of Medicines,basing ontheapplicationfromthe servicereceiverregardingreturn of payment,shallpreparea calculationofestimateexpensesandshallreturnthe appropriatesumviaacreditinstitutiontransactionwithin30calendardaysaftertheapplicationfromtheservicereceiverhasbeenreceivedintheStateAgency of Medicines.Intheapplicationregarding returnofpaymenttheservicereceivershall provide requisitesof thecreditinstitutionandthe accountnumber where the State Agencyof Medicines shalltransfer theappropriatesum.
9.1 Anadditionalfeeintheamountdefinedinsection83oftheAnnexofthis
Regulationshallbeappliedforissueofthedocumentsmentionedinsubsections20.2
1and30.3,sections34,35,351,37,551,61,611,62,621,63,631and82of the Annex of this Regulation in paper format.
9.2 Theprovisionofdataregardingsalesofmedicinalproductstomarketing authorisationholdersmentionedinsection28oftheAnnexofthisRegulationshall be free of charge until January 1st, 2015.
10.The29thJanuary 2013CabinetofMinistersRegulationNo.75“Regulations RegardingtheStateAgency ofMedicinesPublicly AvailablePaidServicePricelist” (“Latvijas Vēstnesis”, 2006, No. 31.)is repealed.
11. TheRegulationsshall enterinto forceon 1st January2014.
12.Section81oftheAnnexofthisRegulationshallcomeintoforceonJanuary1st,
2015.
PrimeMinister V. Dombrovskis
Actingfor theMinister of Health– Minister ofAgricultureL.Straujuma
Annexto
17thJanuary2013
Cabinet of Ministers
Regulation No. 873
StateAgency ofMedicines publicly available paidservicepricelist
Nr. / Service / Unit / Fee(EUR) / VAT (EUR) / Total
(EUR)
1. / Expertise on documentation for marketingauthorisation ofmedicinal productsin the national procedure1
1.1. / first submitted pharmaceutical form
1.1.1. / new activesubstance (except sections 1.1.2. and 1.1.3. ofthis Annex) / application / 5 691.49 / 0.00 / 5 691.49
1.1.2. / known activesubstance, fixed combination (new medicinal product containing at least 2 activesubstances in a combination that has
not been authorised beforeas a medicinal product with a fixed composition), similar biological medicinal products or medicinal products with
well- established medicinal use / application / 4 268.62 / 0.00 / 4 268.62
1.1.3. / essentiallysimilar medicinal products- genericmedicinal products, hybrid application orother application, except applications mentioned in sections 1.4, 1.5, 1.6. and 1.7. ofthis Annex / application / 4 268.62 / 0.00 / 4 268.62
1.2. / eachadditional pharmaceutical form or substitution of active substancewith a different salt, ester complexor isomer, if / application / 2 845.74 / 0.00 / 2 845.74
theydo not differ significantlyin properties with regard to safetyand efficacy
1.3. / eachadditional strength orpackagingof medicinal products, includingsubstitution of activesubstancewith a different salt, ester complexor isomer, if theydo not differ significantlyin properties with regard
to safetyand efficacy, as wellas each application for
medicinal products with identical authorisation documentation, but with different invented
names and with the same oradifferent marketing authorisation holder (multiple applications, if notified simultaneously) / application / 1 422.87 / 0.00 / 1 422.87
1.4. / traditional useherbal medicinal products (herbalmedicinal products authorised in a simplified authorisation procedure)
1.4.1. / composition of threeor less activesubstances / application / 1 422.87 / 0.00 / 1 422.87
1.4.2. / composition morethan threeactivesubstances / application / 2 134.31 / 0.00 / 2 134,31
1.5. / homeopathicmedicinal products with therapeutic
indications / application / 1 422.87 / 0.00 / 1 422.87
1.6. / homeopathicmedicinal products without therapeutic
indications authorised in simplified authorisation procedure / application / 569.15 / 0.00 / 569.15
1.7. / anthroposophic / application / 569.15 / 0.00 / 569.15
medicinal
products described in the officiallyused pharmacopoeia and produced usingthe homeopathicmethod
2. / Expertise on application and additional documentation for renewal of marketing authorisation of medicinal products authorised in thenational procedure1
2.1. / onepharmaceutical form / application / 2 134.31 / 0.00 / 2 134.31
2.1.1. / eachadditional pharmaceutical form / application / 1 138.30 / 0.00 / 1 138.30
2.1.2. / eachadditional strength orpackagingof medicinal
products, as wellas eachapplication for medicinal products with identical authorisation documentation,
but with different invented
names and with the same oradifferent marketing authorisation holder (multiple applications, if notified simultaneously) / application / 711.44 / 0.00 / 711.44
2.2. / traditional useherbal medicinal products / application / 853.72 / 0.00 / 853.72
2.3. / homeopathicmedicinal products with therapeutic
indications / application / 711.44 / 0.00 / 711.44
2.4. / homeopathic medicinal products without therapeuticindications (authorised in
simplified authorisation procedure) / application / 284.57 / 0.00 / 284.57
3. / Expertise on the
Periodic
SafetyUpdate Report fornationally authorised / report / 426.86 / 0.00 / 426.86
medicinal products containingthe same activesubstance(s)of onemarketing authorisation holder1
4. / Expertise on variation documentation for nationallyauthorised medicinal products1,2
4.1. / minor TypeIA
variation / one variation "(except Type I A administrative variations defined in the European Commission Guidelines defined in Article 4, Paragraph 1 of the European CommissionRegulation(EC)No.1234/2008ofNovember24th,2008,concerning theexaminationof variationstotheterms ofmarketingauthorisationsformedicinal productsforhumanuseandveterinarymedicinalproducts(hereinafter - Commission Regulation No. 1234/2008)) / 142.29 / 0.00 / 142.29
4.2. / minor TypeIB
variation / onevariation / 142.29 / 0.00 / 142.29
4.3. / majorTypeIIvariation requiringdetailed scientific evaluation of documentation / onevariation / 426.86 / 0.00 / 426.86
4.4. / majorTypeIIvariation not requiringdetailed scientific evaluation of documentation / onevariation / 213.43 / 0.00 / 213.43
4.5. / majorTypeIIvariation related to the changeof the marketing authorisation
holder (the new marketing
authorisation holder and the current marketing authorisation holder are not thesame person/entity) / onevariation / 142.29 / 0.00 / 142.29
4.6. / changes in package leaflet or labellingthat arenot related to changes in thesummary ofproduct
characteristics / onevariation / 142.29 / 0.00 / 142.29
5. / Expertise on documentation for marketingauthorisation ofmedicinal products
in themutual recognition procedurewhere Latviais a ReferenceMemberState1
5.1. / first submitted pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
5.2. / eachadditional pharmaceutical form application / application / 1 707.45 / 0.00 / 1 707.45
5.3. / eachadditional strength or / application / 853.72 / 0.00 / 853.72
packagingof medicinal product, as wellaseach application for medicinal
products with identical authorisation documentation,
but with different invented
names and with the same oradifferent marketing authorisation holder (multiple applications, if notified simultaneously)
5.4. / forprocedure (in addition tosections 5.1., 5.2. and 5.3. ofthis Annex)
5.4.1. / initial mutual recognition procedure / procedure number / 5674.30 / 0.00 / 5674.30
5.4.2. / repeated mutual recognition procedure / procedure number / 3543.96 / 0.00 / 3543.96
6. / Expertise on application and additional documentation for marketing authorisation of medicinal products in the decentralised procedurewhere Latvia is a ReferenceMemberState1
6.1. / first submitted pharmaceutical form
6.1.1. / new activesubstance / application / 14 228.72 / 0.00 / 14 228.72
6.1.2. / known activesubstance, fixed combination, similar biological medicinal products or medicinal products with well-established medicinal use / application / 5 691.49 / 0.00 / 5 691.49
6.1.3. / essentiallysimilar medicinal
products-generic medicinal products, hybrid application
orother application / application / 4 268.62 / 0.00 / 4 268.62
6.2. / eachadditional pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
6.3. / eachadditional strength / application / 1 422.87 / 0.00 / 1 422.87
orpackagingof medicinal
products, as wellas eachapplication for medicinal
products with identical authorisation documentation,
but with different invented names and with thesameor a different marketing authorisation holder (multiple applications,
if notified simultaneously)
6.4. / forprocedure (in addition to sections 6.1.,
6.2. and 6.3. ofthis
Annex) / procedure number / 9923.32 / 0.00 / 9923.32
7. / Expertise on application andadditional documentationformarketing authorisation of medicinal products in the mutual recognition procedurewhere LatviaisaConcerned MemberState1
7.1. / first submitted pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
7.1.1. / eachadditional pharmaceutical form / application / 1 422.87 / 0.00 / 1 422.87
7.1.2. / eachadditional strength orpackagingof medicinal
product, as wellaseach application for medicinal
products with identical authorisation documentation,
but with different invented
names and with thesame oradifferent marketing authorisation holder (multiple applications, if notified
simultaneously) / application / 711.44 / 0.00 / 711.44
8. / Expertise on application and additional documentation for marketing
authorisation of medicinal products in the decentralised procedurewhere Latviais a
Concerned MemberState1
8.1. / first submitted pharmaceutical form / application / 4 268.62 / 0.00 / 4 268,62
8.1.1. / eachadditional pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
8.1.2. / eachadditional strength orpackagingof medicinal product, as wellas each
application for
medicinal products with identical authorisation documentation,
but with different invented names and with thesameor a different marketing authorisation holder (multiple applications, if notified simultaneously) / application / 1 422.87 / 0.00 / 1 422.87
9. / Expertise on application and additional documentation for renewal of marketing authorisation of medicinal products in the mutual recognition and decentralised procedurewhere Latviais
9.1. / ReferenceMemberState(RMS)1
9.1.1. / single pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
9.1.2. / eachadditional pharmaceutical form / application / 1 422.87 / 0.00 / 1 422.87
9.1.3. / eachadditional strength orpackagingof medicinal product, as wellas each
application for
medicinal products with identical authorisation documentation,
but with different invented names and with thesameor a different marketing authorisation holder (multiple applications, if notified simultaneously) / application / 711.44 / 0.00 / 711.44
9.1.4. / forprocedure (in addition to sections
9.1.1., 9.1.2. and 9.1.3. ofthis Annex) / procedure number / 4 268.62 / 0.00 / 4 268.62
9.2. / Concerned MemberState
(CMS)1
9.2.1. / first submitted pharmaceutical form / application / 2 845.74 / 0.00 / 2 845.74
9.2.2. / eachadditional pharmaceutical form / application / 1 422.87 / 0.00 / 1 422.87
9.2.3. / eachadditional strength orpackagingof medicinal product, as wellas each
application for
medicinal products with identical
authorisation documentation, but with different
invented names and with thesameor a different marketing authorisation holder (multiple applications, if notified simultaneously) / application / 711.44 / 0.00 / 711.44
10. / Expertise on PeriodicSafetyUpdate Report for medicinal products authorised in the mutual recognition and decentralised procedurewhere LatviaisaReference Member State1
10.1. / medicinal products with oneor several identical activesubstances / report / 1 422.87 / 0.00 / 1 422.87
10.2. / forprocedure (in addition to section 10.1. ofthis Annex) / procedure number / 1 422.87 / 0.00 / 1 422.87
11. / Expertise on variation documentation for medicinal products authorised inthe mutual recognition and decentralisedprocedure1
11.1. / minor TypeIA
variation2 / single variation (except Type I A administrative variations defined in the European Commission Guidelines of Article 4, paragraph 1 of the Commission Regulation No 1234/2008)"; / 142.29 / 0.00 / 142.29
11.2. / minor TypeIB
variation2 / single variation / 142.29 / 0.00 / 142.29
11.3. / majorTypeIIvariation requiringdetailed scientific / single variation / 426.86 / 0.00 / 426.86
evaluation of documentation2
11.4. / majorTypeIIvariation not
requiringdetailed scientific evaluation of documentation2 / single variation / 213.43 / 0.00 / 213.43
11.5. / majorTypeIIvariation related to the changeof the
marketing authorisation holder2 / single variation / 142.29 / 0.00 / 142.29
11.6. / changes in package leaflet or labellingnot related to changesin the summaryof product characteristics2 / single variation / 142.29 / 0.00 / 142.29
11.7. / forprocedure,whereLatvia is aReferenceMemberState
11.7.1. / majorTypeIIvariation requiringdetailed scientific evaluation of documentation / oneprocedure / 853.72 / 0.00 / 853.72
11.7.2. / other changes, except changes mentioned in section 11.7.1. ofthis Annex / oneprocedure / 426.86 / 0.00 / 426.86
12. / Post- authorisation maintenancefee(annual)1
12.1. / eachauthorised pharmaceutical form and strength (except medicinal products mentioned in the section 13 ofthis Annex) / marketing authorisation number / 498.01 / 0.00 / 498.01
12.2. / traditional useherbal medical products and diagnostic medicinal products / marketing authorisation number / 142.29 / 0.00 / 142.29
12.3. / homeopathic medicinal products with therapeutic
indications / marketing authorisation number / 142.29 / 0.00 / 142.29
12.4. / homeopathicmedicinal products without / marketing authorisation / 42.69 / 0.00 / 42.69
therapeutic
indications (authorised in simplified authorisation procedure) and anthroposophic medicinal products / number
13. / Evaluation of product (e.g. food supplement, cosmetics, biocide, medical device)compliancewiththe definition ofamedicinal product1
13.1. / product where evaluation of documentation does not requiredetailed scientific
expertise / application / 426.86 / 0.00 / 426.86
13.2. / detailed scientific expertise on product composition and pharmacological properties / application / 853.72 / 0.00 / 853.72
14. / Expertise on application and documentation for distribution of and variations to parallel imported medicinal
products inLatvia1 / expertise / 301.46 / 0.00 / 301.46
14.1. / variations to package leaflet / expertise / 71.14 / 0.00 / 71.14
14.2. / variations to labelling / expertise / 71.14 / 0.00 / 71.14
14.3. / variations to documentation
(changeof legaladdress ofmerchant) / expertise / 71.14 / 0.00 / 71.14
15. / Expertise on application and documentation for distribution of unauthorised, individuallyapproved medicinal products (in thecasementioned in Section 10, Paragraph 7(a) of thePharmaceuticalLaw)1
15.1. / first record of medicinal product in documentation / expertise / 0.71 / 0.00 / 0.71
15.2. / each followingrecord ofmedicinal product in documentation / expertise / 0.71 / 0.00 / 0.71
16. / Expertise on application and documentation for distribution of unauthorised, individuallyapproved medicinal products(in thecases described in Section 10,
Paragraph 7(b) and 7(c)ofthe PharmaceuticalLaw)1
16.1. / first record of medicinal product in documentation
expertise / expertise / 21.34 / 0.00 / 21.34
16.2. / each followingrecord ofmedicinal product in documentation / expertise / 6.76 / 0.00 / 6.76
17. / Expertise on application and documentation for import of medicinal product samples1
17.1. / up to 5 records ofa medicinal product / expertise / 7.11 / 0.00 / 7.11
17.2. / each followingrecord ofmedicinal product / expertise / 1.42 / 0.00 / 1.42
18. / Expertise on application and additional documentation ofapharmaceutical activitycompanyin thefollowingcases1
18.1. / changeof legal status or typemerchant, or transfer of aconstant part ofthe companyof the Merchant / expertise on documentation
of1 pharmaceutical activitycompany / 71.14 / 0.00 / 71.14
18.2. / changeof pharmacy director, responsible person forawholesale distributor ofmedicinal products, qualified person ofacompany manufacturingor importingmedicinal products, person responsible for manufacturing
activepharmaceutical ingredients or controlled
substances, head of the structural unit for qualitycontrol or manufacturing,
person responsible for fulfillingrequirements forspecialactivityat a manufacturingor importingcompany(as wellas change
ofsurname) / expertise on documentation for1 person / 71.14 / 0.00 / 71.14
18.4. / changeof legal address ofthe merchant
or changeof pharmaceutical activity companyaddress / expertise on documentation of1 pharmaceutical activity company / 71.14 / 0.00 / 71.14
18.5. / changeof surname of an
individual merchant / expertise on documentation for1 person / 71.14 / 0.00 / 71.14
18.6. / regardingtheclosureof apharmacybranch or a department of medicinal products wholesaler / expertise on documentation
of1 pharmaceutical activity company / 42.69 / 0.00 / 42.69
18.7. / regardingthe suspension of
special permit (licence) forpharmaceutical activity / expertise on documentation
of1 pharmaceutical activity company / 42,69 / 0.00 / 42,69
18.8. / regardingthe suspension
ofoperation ofa pharmacy
branch or medicinal products
wholesaler / expertise on documentation
of1 pharmaceutical activity company / 42.69 / 0.00 / 42.69
18.9. / regarding changes in the
special permit (licence) forpharmaceutical activity(including expiration date) and its annexes, if evaluation ofthe complianceof pharmaceutical activity
companyis not required / expertise on documentation
of1 pharmaceutical activity company / 42.69 / 0.00 / 42.69
18.10. / changes in documentation and information, if renewal / expertise on documentation
of1 pharmaceutical / 42.69 / 0.00 / 42.69
ofspecial permit (licence) for pharmaceutical activity is notrequired / activity company
18.11. / renewal of special permit (licence) for pharmaceutical
activity, if evaluation of complianceof
the pharmaceutical activitycompanyis not required / 1 expertise / 71.14 / 0.00 / 71.14
18.12. / renewal of special permit (licence) for pharmaceutical activityorrenewal of special activity requirements stated
in thespecial permit (licence) for pharmaceutical activity, orrenewal of manufacturing
orimport ofspecific medicinal products, if evaluation of
complianceof
the pharmaceutical activitycompanyis not required / expertise on documentation of1 pharmaceutical activity company / 42.69 / 0.00 / 42.69
18.13. / expertise on documentation
ofapharmaceutical activitycompany, if manufacturingor import ofmaterials is beinginitiated (is carried out) / expertise on documentation of1 pharmaceutical
activitycompany / 42.69 / 0.00 / 42.69
18.14. / Reviewof application from themerchant regarding approval of pharmaceutical activitysite (address) / expertise on 1 pharmaceutical activitysite (address) / 71.14 / 0.00 / 71.14
19. / Evaluation of initiation ofpharmacyoperation, initiation ofoperation at a new pharmaceutical activitysite (room), initiation of carryingout newspecial activityrequirementsanddocumentation (verification) on procedures for operation1
19.1. / general typepharmacy
19.1.1. / if thepharmacyis located in a city / expertise on documentation of1 pharmacy / 142.29 / 0.00 / 142.29
19.1.2. / if thepharmacyis located in a cityand it has onebranch / expertise on documentation of1 pharmacy and 1 branch / 113.83 / 0.00 / 113.83
19.1.3. / if thepharmacyis located in a cityand it has morethan one branch / expertise on documentation of1 pharmacy and its branches / 99.60 / 0.00 / 99.60
19.1.4. / if thepharmacyis located in rural area / expertise on documentation of1 pharmacy / 71.14 / 0.00 / 71.14
19.1.5. / if thepharmacyis located in a rural area and ithas onebranch / expertise on documentation of1 pharmacy / 56.91 / 0.00 / 56.91
19.1.6. / if thepharmacyis located in a rural area and ithas morethan onebranch / expertise on documentation of1 pharmacy and its branches / 49.80 / 0.00 / 49.80
19.2. / closed typepharmacy / expertise on documentation of1 pharmacy / 64.03 / 0.00 / 64.03
19.3. / onepharmacybranch, if expertise on pharmacy documentation is not conducted / expertise on documentation
of1 pharmacybranch / 49.80 / 0.00 / 49.80
20. / Evaluation of complianceof pharmaceutical activitycompany(medicinalproducts wholesaler, medicinal products manufacturing company)1
20.1. / medicinal products manufacturingor import / expertise on documentation
1 medicinal products manufacturing
orimport company / 569.15 / 0.00 / 569.15
20.2. / medicinal products manufacturing company / expertise on documentation
1 medicinal products manufacturing company / 426.86 / 0.00 / 426.86
20.3. / medicinal products manufacturing(partial manufacturingprocess) / expertise on documentation
1 medicinal products / 426.86 / 0.00 / 426.86
company / manufacturing company
20.4. / medicinal products manufacturing company that manufactures only investigational
medicinal products / expertise on documentation
1 medicinal products manufacturing company / 284.57 / 0.00 / 284.57
20.5. / medicinal products wholesaler / expertise on documentation of1 medicinal products wholesaler / 426.86 / 0.00 / 426.86
20.6. / department of medicinal productswholesaler / expertise on documentation of1 department ofmedicinal products wholesaler / 99.60 / 0.00 / 99.60
20.7. / companymanufacturing activesubstances or controlled medicinal products / expertise on documentation of1 medicinal products
manufacturingcompany / 426.86 / 0.00 / 426.86
20.8. / companycarryingout onlyethyl alcohol packaging / expertise on documentation of1 medicinal products manufacturing companyor wholesaler / 284.57 / 0.00 / 284.57
20.1 / Expertise on documentation of a merchant or performer of economic activities that is manufacturing, importing or distributing active substances
20.11. / expertise on documentation, processing of authorisation data, if the number of manufactured, imported or distributed active substances is from1 to 5 / expertise / 70.92 / 0.00 / 70.92
20.12. / expertise on documentation, processing of authorisation data for each additional manufactured, imported or distributed active substance / expertise / 14.18 / 0.00 / 14.18
20.13. / expertise on documentation formanufacturing,import or distribution of active substances, if variations have been made, including changes in the place of
operation,inmanufacturing, importing or distribution activities / expertise / 71.08 / 0.00 / 71.08
20.2 / Expertise on documentation of a merchant or performer of economic activities that carries outintermediary transactionswith medicinal products1
20.21. / expertise on documentation and issue of authorisation / authorisation / 41.12 / 0.00 / 41.12
20.22. / expertise on documentation regarding variations to the information submitted for authorisation / application / 14.18 / 0.00 / 14.18
21. / Preparation and printing ofsubmitted materials / 1 page / 1.21 / 0.26 / 1.47
22. / Reviewof clinical trial application and additional documentation1 / 1 expertise / 1 422.87 / 0.00 / 1 422.87
23. / Evaluation of compliancewith goodclinical practiceof a clinical trial center or institutions related to clinical trials in aEuropeanEconomicAreamemberstate in connection with a marketingauthorisation application1
23.1. / oneday(oneinspector) / 1 clinical trial center/ related institution / 350.03 / 0.00 / 350.03
23.2. / two days(one inspector) / 1 clinical trial center/ related institution / 443.94 / 0.00 / 443.94
23.3. / threedays (one inspector) / 1 clinical trial center/ related institution / 537.85 / 0.00 / 537.85
23.4. / fourdays (one inspector) / 1 clinical trial center/ related institution / 631.76 / 0.00 / 631.76
23.5. / fivedays (one inspector) / 1 clinical trial center/ related institution / 725.66 / 0.00 / 725.66
24. / Evaluation of compliancewith goodclinical practiceof a clinical trial center or institutions related to clinical trials notlocated in aEuropean EconomicArea member state in connection with a marketingauthorisation application1
24.1. / oneday(oneinspector) / 1 clinical trial center/ related institution / 640.29 / 0.00 / 640.29
24.2. / two days(one inspector) / 1 clinical trial center/ related institution / 811.04 / 0.00 / 811.04
24.3. / threedays (one inspector) / 1 clinical trial center/ related institution / 981.78 / 0.00 / 981.78
24.4. / fourdays (one inspector) / 1 clinical trial center/ relatedinstitution / 1 109.84 / 0.00 / 1 109.84
24.5 / fivedays (one inspector) / 1 clinical trial center/ relatedinstitution / 1 294.81 / 0.00 / 1 294.81
25. / Reviewof amendments to the clinical trial protocol1 / 1 amendment / 213.43 / 0.00 / 213.43
26. / Reviewof application and additional documentation for
anon-interventional studyproposedbya medicinal product manufacturer (its representative)1 / 1 expertise / 284.57 / 0.00 / 284.57
27. / Expertise on application and documentation for import or export of psychotropic and narcoticsubstances and medicinal products, as wellas precursors1 / expertise / 21.34 / 0.00 / 21.34
28. / Provision of data regarding sales of medicinal products 1
28.1. / Standard overview of data regarding sales of medicinal products (the overview includes the Anatomical Therapeutic Chemical Classification Systemcode (ATC code), the international non-proprietary name (INN), pharmaceutical form, strength or concentration of medicinal product, amount of medicinal product in the packaging, number of packages sold, turnover in euros)
28.1.1
. / quarter subdivided into months / overview / 496.71 / 0.00 / 496.71
28.1.2
. / 6months / overview / 851.54 / 0.00 / 851.54
28.1.3
. / 1 year / overview / 1 419.20 / 0.00 / 1 419.20
28.2. / Expanded overview of data regarding sales of medicinal products (includes the information contained by the standard overview and in addition indicates the group of medicinal product consumers or the classification group to which the medicinal product belongs)
28.2.1
. / quarter subdivided into months / overview / 603.16 / 0.00 / 603.16
28.2.2
. / 6months / overview / 993.42 / 0.00 / 993.42
28.2.3
. / 1 year / overview / 1 774.01 / 0.00 / 1 774.01
28.3. / Complete overview of data regarding sales of medicinal products (includes the information contained by the standard overview and in addition indicates the group of medicinal product consumers and the classification group to which the medicinal product belongs)
28.3.1
. / quarter subdivided into months / overview / 674.11 / 0.00 / 674.11
28.3.2
. / 6months / overview / 1 135.34 / 0.00 / 1 135.34
28.3.3
. / 1 year / overview / 1 986.87 / 0.00 / 1 986.87
28.4. / Individual overview of data regarding sales of medicinal products / parameter / 13.70 / 0.00 / 13.70
29. / Expertise on medicinal product fordistribution ofremainingstock1
29.1. / the medicinal product has not been renewed or theirrenewal has been denied / for1 medicinal product / 14.23 / 0.00 / 14.23
29.2. / variations to the marketing authorisation documentation / for1 medicinal product / 14.23 / 0.00 / 14.23