prop · GY0344 · 2010-12-21 00:00:00 — 3.Where an advanced therapy medicinal product contains humancellsortissues,themarketingauthorisationholder,aswell as the hospital, institution or private practice where the product is used, shall ensure that the traceability systems established in accordance with paragraphs 1 and 2 of this Article are comple- mentary to, and compatible with, the requirements laid down in Articles8and14ofDirective2004/23/ECasregardshumancells and tissues other than blood cells, and Articles 14 and 24 of Directive 2002/98/EC as regards human blood cells. 4.The marketing authorisation holder shall keep the data referred to in paragraph 1 for a minimum of 30 years after the expiry date of the product, or longer if required by the Commis- sion as a term of the marketing authorisation. 5.Incaseofbankruptcyorliquidationofthemarketingautho- risation holder, and in the event that the marketing authorisation is not transferred to another legal entity, the data referred to in paragraph 1 shall be transferred to the Agency. 6.In the event that the marketing authorisation is suspended, revoked or withdrawn, the holder of the marketing authorisation shallremainsubjecttotheobligationslaiddowninparagraphs1, 3 and 4. 7.The Commission shall draw up detailed guidelines relating totheapplicationofparagraphs1to6,inparticularthetypeand amount of data referred to in paragraph 1. The applicant or holder of a marketing authorisation may request advice from the Agency on the design and conduct of pharmacovigilanceandoftheriskmanagementsystemreferredto in Article 14. L 324/128 By way of derogation from Article 8(1) of Council Regula- tion (EC) No 297/95 of 10 February 1995 on fees payable to the for the Evaluation of (1), a 90 %reductionforsmallandmedium-sizedenterprisesand65 % forotherapplicantsshallapplytothefeeforscientificadvicepay- able to the Agency for any advice given in respect of advanced therapy medicinal products pursuant to paragraph 1 of this Article and Article 57(1)(n) of Regulation (EC) No 726/2004. 2.Paragraph 1 shall also apply to fees charged by the Agency for post-authorisation activities in the first year following the grantingofthemarketingauthorisationfortheadvancedtherapy medicinal product. 3.Paragraphs 1 and 2 shall apply during the transitional peri- ods laid down in Article 29. Scientific recommendation on advanced therapy classification 1.Anyapplicantdevelopingaproductbasedongenes,cellsor tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinalproduct.TheAgencyshalldeliverthisrecommendation after consultation with the Commission and within 60 days after receipt of the request. 2.The Agency shall publish summaries of the recommenda- tions delivered in accordance with paragraph 1, after deletion of all information of commercial confidential nature. Certification of quality and non-clinical data Small and medium-sized enterprises developing an advanced therapymedicinalproductmaysubmittotheAgencyallrelevant quality and, where available, non-clinical data required in accor- dancewithmodules3and4ofAnnexItoDirective2001/83/EC, for scientific evaluation and certification. TheCommissionshalllaydownprovisionsfortheevaluationand certification of such data, in accordance with the regulatory pro- cedure referred to in Article 26(2). Reduction of the fee for marketing authorisation BywayofderogationfromRegulation(EC)No297/95,the fee for marketing authorisation shall be reduced by if the applicant is a hospital or a small or medium-sized enterprise and can prove that there is a particular public health interest in the Community in the advanced therapy medicinal product concerned. (1) OJ L 35, , p. Regulation as last amended by Regulation (EC) No 1905/2005 (OJ L 304, 23.11.2005, p. COMMITTEE FOR ADVANCED THERAPIES 1.A shall be established within the Agency. 2.Save where otherwise provided in this Regulation, Regula- tion (EC) No 726/2004 shall apply to . 3.The Executive Director of the Agency shall ensure appro- priatecoordinationbetweentheCommitteeforAdvancedThera- pies and the other Committees of the Agency, in particular for Human Use and the Com- mittee for , their working parties and any other scientific advisory groups. shall be composed of the following members: (a)five members or co-opted members of , with alternates either proposed by their respective or, in the case of co-opted members of for Human Use, identified by the lat- ter on the advice of the corresponding co-opted member. These five members with their alternates shall be appointed by for Human Use; (b)one member and one alternate appointed by each whose national competent authority is not represented among the members and alternates appointed by the Com- mittee for for Human Use; (c)two members and two alternates appointed by the Commis- sion, on the basis of a public call for expressions of interest and after consulting Parliament, in order to represent clinicians; L 324/129 (d)two members and two alternates appointed by the Commis- sion, on the basis of a public call for expressions of interest and after consulting Parliament, in order to represent patients associations. The alternates shall represent and vote for the members in their absence. All members of shall be chosen for their scientific qualification or experience in respectofadvancedtherapymedicinalproducts.Forthepurposes of paragraph 1(b), the Member States shall cooperate, under the coordination of the Executive Director of the Agency, in order to ensurethatthefinalcompositionoftheCommitteeforAdvanced Therapies provides appropriate and balanced coverage of the sci- entific areas relevant to advanced therapies, including devices,tissueengineering,genetherapy,celltherapy,biotechnol- ogy, surgery, pharmacovigilance, risk management and ethics. At least two members and two alternates of shall have scientific expertise in devices. 3.The members of shallbeappointedforarenewableperiodofthreeyears.Atmeet- ings of , they may be accompanied by experts. 4.TheCommitteeforAdvancedTherapiesshallelectitsChair- man from among its members for a term of three years, renew- able once. 5.Thenamesandscientificqualificationsofallmembersshall be made public by the Agency, in particular on the Agencys website. In addition to the requirements laid down in Article 63 of Regu- lation (EC) No 726/2004, members and alternates of the Com- mittee for Advanced Therapies shall have no financial or other interests in the biotechnology sector and device sector thatcouldaffecttheirimpartiality.Allindirectintereststhatcould relatetothesesectorsshallbeenteredintheregisterreferredtoin Article 63(2) of Regulation (EC) No 726/2004. shall have the following tasks: (a)to formulate a draft opinion on the quality, safety and effi- cacy of an advanced therapy medicinal product for final approval by for Human Use and to advise the latter on any data generated in the development of such a product; (b)toprovideadvice,pursuanttoArticle17,onwhetheraprod- uctfallswithinthedefinitionofanadvancedtherapymedici- nal product; (c)at the request of for Human Use, to advise on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in one of the scientific areas referred to in Article 21(2); (d)to provide advice on any question related to advanced therapy medicinal products, at the request of the Executive Director of the Agency or the Commission; (e)to assist scientifically in the elaboration of any documents related to the fulfilment of the objectives of this Regulation; (f)at the Commissions request, to provide scientific expertise andadviceforanyCommunityinitiativerelatedtothedevel- opmentofinnovativemedicinesandtherapieswhichrequires expertise in one of the scientific areas referred to in Article 21(2); (g)tocontributetothescientificadviceproceduresreferredtoin Article16ofthisRegulationandinArticle57(1)(n)ofRegu- lation (EC) No 726/2004. GENERAL AND FINAL PROVISIONS The Commission shall, after consulting the Agency and in accor- dance with the regulatory procedure with scrutiny referred to in Article 26(3), amend Annexes I to IV in order to adapt them to scientific and technical evolution. By , the Commission shall publish a general report on the application of this Regulation, which shall include comprehensive information on the different types of advanced therapy medicinal products authorised pursuant to this Regulation. In this report, the Commission shall assess the impact of techni- cal progress on the application of this Regulation. It shall also review the scope of this Regulation, including in particular the regulatory framework for combined advanced therapy medicinal products. L 324/130 1.TheCommissionshallbeassistedbytheStandingCommit- teeonMedicinalProductsforHumanUsesetupbyArticle121(1) of Directive 2001/83/EC. 2.Wherereferenceismadetothisparagraph,Articles5and7 of Decision 1999/468/EC shall apply, having regard to the pro- visions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. Amendments to Regulation (EC) No 726/2004 Regulation (EC) No 726/2004 is hereby amended as follows: 1.in the first subparagraph of Article 13(1), the first sentence shall be replaced by the following: Without prejudice to Article 4(4) and (5) of Directive 2001/83/EC, a marketing authorisation which has been granted in accordance with this Regulation shall be valid throughout the Community. 2.Article 56 shall be amended as follows: (a)in paragraph 1, the following point shall be inserted: (da) ; (b)in the first sentence of the first subparagraph of para- graph 2, the words paragraph 1(a) to (d) shall be replaced by paragraph 1(a) to (da); 3.the be amended as follows: (a)the following point shall be inserted: Advanced therapy medicinal products as defined in Article 2 of Regulation (EC) No 1394/2007 of Parliament and of products (*). (*) OJ L 324, 10.12.2007, p. (b)Inpoint3,thesecondsubparagraphshallbereplacedby the following: After 20 2008, the Commission, having consulted the Agency, may present any appropriate proposal to amend this point and Parliament and the Councilshalltakeadecisionthereoninaccordancewith the Treaty. Amendments to Directive 2001/83/EC Directive 2001/83/EC is hereby amended as follows: 1.in Article 1, the following point shall be inserted: Advanced therapy medicinal product: A product as defined in Article 2 of Regulation (EC) No 1394/2007 of Parliament and of the Council of on advanced therapy medicinal products (*). (*) OJ L 324, 10.12.2007, p. 2.in Article 3, the following point shall be added: Anyadvancedtherapymedicinalproduct,asdefinedin Regulation (EC) No 1394/2007, which is prepared on a non-routine basis according to specific quality stan- dards, and used within the same in a hospital under the exclusive professional responsibil- ity of a practitioner, in order to comply with an individual prescription for a custom-made product for an individual patient. Manufacturingoftheseproductsshallbeauthorisedby thecompetentauthorityoftheMemberState.Member States shall ensure that national traceability and phar- macovigilance requirements as well as the specific quality standards referred to in this paragraph are equivalenttothoseprovidedforatCommunitylevelin respect of advanced therapy medicinal products for whichauthorisationisrequiredpursuanttoRegulation (EC) No 726/2004 of Parliament and of 2004 laying down Commu- nity procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a (*). (*) OJ L 136, 30.4.2004, p. Regulation as amended by Regulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, 3.in Article 4, the following paragraph shall be added: This Directive and all Regulations referred to therein shallnotaffecttheapplicationofnationallegislationprohib- iting or restricting the use of any specific type of human or animal cells, or the sale, supply or use of medicinal products containing, consisting of or derived from these cells, on grounds not dealt with in the aforementioned Community legislation. The Member States shall communicate the nationallegislationconcernedtotheCommission.TheCom- mission shall make this information publicly available in a register. L 324/131 4.inArticle6(1),thefirstsubparagraphshallbereplacedbythe No medicinal product may be placed on the market of a unless a marketing authorisation has been issued by the competent authorities of that in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007. Advanced therapy medicinal products, other than tissue engineeredproducts,whichwerelegallyontheCommunitymar- ket in accordance with national or Community legislation on , shall comply with this Regulation no later than . 2.TissueengineeredproductswhichwerelegallyontheCom- munity market in accordance with national or Community legis- lation on shall comply with this Regulation no later than . 3.By way of derogation from Article 3(1) of Regulation (EC) No 297/95, no fee shall be payable to the Agency in respect of applications submitted for the authorisation of the advanced therapy medicinal products mentioned in paragraphs 1 and 2 of this Article. This Regulation shall enter into force on the 20th day following its publication in the . It shall apply from . This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at , . M. LOBO ANTUNES L 324/132 Manipulations referred to in the first indent of Article 2(1)(c) soaking in antibiotic or antimicrobial solutions, cell separation, concentration or purification, L 324/133 Summary of product characteristics referred to in Article 10 1.Name of the medicinal product. 2.Composition of the product: 2.1.general description of the product, if necessary with explanatory drawings and pictures, 2.2.qualitativeandquantitativecompositionintermsoftheactivesubstancesandotherconstituentsoftheproduct,knowl- edge of which is essential for proper use, administration or implantation of the product. Where the product contains cells or tissues, a detailed description of these cells or tissues and of their specific origin, including the species of ani- mal in cases of non-human origin, shall be provided, For a list of excipients, see point 6.1. 4.2.posology and detailed instructions for use, application, implantation or administration for adults and, where neces- sary, for children or other special populations, if necessary with explanatory drawings and pictures, 4.4.specialwarningsandprecautionsforuse,includinganyspecialprecautionstobetakenbypersonshandlingsuchprod- ucts and administering them to or implanting them in patients, together with any precautions to be taken by the patient, 4.5.interaction with other medicinal products and other forms of interactions, 4.6.use during pregnancy and lactation, 4.7.effects on ability to drive and to use , 4.9.overdose (symptoms, emergency procedures). 5.3.preclinical safety data. 6.1.list of excipients, including preservative systems, 6.3.shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time, L 324/134 6.4.special precautions for storage, 6.5.nature and contents of container and special equipment for use, administration or implantation, if necessary with explanatory drawings and pictures, 6.6.specialprecautionsandinstructionsforhandlinganddisposalofausedadvancedtherapymedicinalproductorwaste materials derived from such product, if appropriate and, if necessary, with explanatory drawings and pictures. 7.Marketing authorisation holder. 8.Marketing authorisation number(s). 9.Date of the first authorisation or renewal of the authorisation. 10.Date of revision of the text. L 324/135 Labelling of outer/immediate packaging referred to in Article 11 (a)The name of the medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults; the international non-proprietary name (INN) shall be included, or, if the product has no INN, the common name; (b)A description of the substance(s) expressed qualitatively and quantitatively, including, where the product con- tainscellsortissues,thestatementThisproductcontainscellsofhuman/animal[asappropriate{]origintogetherwith a short description of these cells or tissues and of their specific origin, including the species of animal in cases of non- human origin; (c)The pharmaceutical form and, if applicable, the contents by weight, by volume or by number of doses of the product; (d)A list of excipients, including preservative systems; (e)The method of use, application, administration or implantation and, if necessary, the route of administration. If appli- cable, space shall be provided for the prescribed dose to be indicated; (f)A special warning that the medicinal product must be stored out of the reach and sight of children; (g)special warning necessary for the particular medicinal product; (h)The expiry date in clear terms (month and year; and day if applicable); (i)Special storage precautions, if any; (j)Specific precautions relating to the disposal of unused medicinal products or waste derived from medicinal products, where appropriate, as well as reference to any appropriate collection system in place; (k)The name and address of the marketing authorisation holder and, where applicable, the name of the representative appointed by the holder to represent him; (l)Marketing authorisation number(s); (m)The manufacturers batch number and the unique donation and product codes referred to in Article 8(2) of Directive 2004/23/EC; (n)In the case of advanced therapy medicinal products for autologous use, the unique patient identifier and the statement For autologous use only. L 324/136 Package leaflet referred to in Article 13 (a)For the identification of the advanced therapy medicinal product: (i)the name of the advanced therapy medicinal product and, if appropriate, an indication of whether it is intended for babies, children or adults. The common name shall be included; (ii)the therapeutic group or type of activity in terms easily understandable for the patient; (iii)wheretheproductcontainscellsortissues,adescriptionofthosecellsortissuesandoftheirspecificorigin,includ- ing the species of animal in cases of non-human origin; (iv)where the product contains devices or implantable devices, a description of those devices and their specific origin; (b)The therapeutic indications; (c)A list of information which is necessary before the medicinal product is taken or used, including: (i)contra-indications; (ii)appropriate precautions for use; (iii)forms of interaction with other medicinal products and other forms of interaction (e.g. alcohol, tobacco, food- stuffs) which may affect the action of the medicinal product; (iv)special warnings; (v)if appropriate, possible effects on the ability to drive vehicles or to operate machinery; (vi)theexcipients,knowledgeofwhichisimportantforthesafeandeffectiveuseofthemedicinalproductandwhich are included in the detailed guidance published pursuant to Article 65 of Directive 2001/83/EC. Thelistshallalsotakeintoaccounttheparticularconditionofcertaincategoriesofusers,suchaschildren,pregnantor breastfeeding women, the elderly, persons with specific pathological conditions; (d)The necessary and usual instructions for proper use, and in particular: (i)the posology; (ii)the method of use, application, administration or implantation and, if necessary, the route of administration; and, as appropriate, depending on the nature of the product: (iii)the frequencyofadministration,specifyingifnecessary theappropriatetimeat whichthemedicinalproduct may or must be administered; (iv)the duration of treatment, where it should be limited; (v)the action to be taken in case of an overdose (such as symptoms, emergency procedures); (vi)information on what to do when one or more doses have not been taken; (vii)a specific recommendation to consult the doctor or the pharmacist, as appropriate, for any clarification on the use of the product; (e)A description of the adverse reactions which may occur under normal use of the medicinal product and, if necessary, theactiontobetakeninsuchacase;thepatientshouldbeexpresslyaskedtocommunicateanyadversereactionwhich is not mentioned in the package leaflet to his doctor or pharmacist; L 324/137 (f)A reference to the expiry date indicated on the label, with: (i)a warning against using the product after that date; (ii)where appropriate, special storage precautions; (iii)if necessary, a warning concerning certain visible signs of deterioration; (iv)the full qualitative and quantitative composition; (v)thenameandaddressofthemarketingauthorisationholderand,whereapplicable,thenameofhisappointedrep- resentatives in the Member States; (vi)the name and address of the manufacturer; (g)The date on which the package leaflet was last revised. L 87/174 Europeiska unionens officiella tidning Rättelse till och rådets förordning (EG) nr 1394/2007 av om läkemedel för avancerad terapi och om ändring av direktiv /83/EG och förordning (EG) nr 726/2004 (Europeiska unionens officiella tidning 324 av På sidan 131, artikel 28, ändringar av direktiv /83/EG, led 4, ska det i stället för: Artikel 6.1 första stycket ska ersättas med följande: Ett läkemedel får saluföras i en medlemsstat endast om den behöriga myndigheten i medlemsstaten har meddelat godkännande för försäljning enligt detta direktiv, eller om godkännande har meddelats enligt förordning (EG) nr 726/2004, jämförd med förordning (EG) nr 1394/2007. Artikel 6.1 första stycket ska ersättas med följande: Ett läkemedel får saluföras i en medlemsstat endast om den behöriga myndigheten i medlemsstaten har meddelat godkännande för försäljning enligt detta direktiv, eller om godkännande har meddelats enligt förordning (EG) nr 726/2004, jämförd med och rådets förordning (EG) nr 1901/2006 av om läkemedel för pediatrisk användning (*) och förordning (EG) nr 1394/2007. (*)EUT L 378, 27.12.2006, s. 1.. L 87/174 Corrigendum to Regulation (EC) No 1394/2007 of Parliament and of the Council of on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (L 324 of ) On page 131, Article 28, Amendments to Directive 2001/83/EC, point 4: 4. in Article 6(1), the first subparagraph shall be replaced by the following: No medicinal product may be placed on the market of a unless a marketing authorisation has been issued by the competent authorities of that in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1394/2007., 4. in Article 6(1), the first subparagraph shall be replaced by the following: No medicinal product may be placed on the market of a unless a marketing authorisation has been issued by the competent authorities of that in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004, read in conjunction with Regulation (EC) No 1901/2006 of Parliament and of the Council of on medicinal products for paediatric use (*) and Regulation (EC) No 1394/2007. (*)OJ L 378, 27.12.2006, p. Författningsförslag i promemorian om Genomförande av bestämmelsen om sjukhusundantag (Ds 2010:13) 1Förslag till lag om ändring i läkemedelslagen (1992:859) Härigenom föreskrivs1 i fråga om läkemedelslagen (1992:859) dels att 14, 16, 23 och 24 §§ ska ha följande lydelse,