The centralised procedure (CP) makes provision for submission of a single new marketing authorisation application (MAA) to the EMA with scientific assessment being conducted by a rapporteur/co-rapporteur, and assess- ment of the risk management plan by the Pharmacovigilance Risk Assessment Committee (PRAC). 0000005706 00000 n 0000006198 00000 n 0000011882 00000 n 0000005280 00000 n

_�^� Ğ�H(R7�J�菚�8)R����}�����Hğ>���?����������]�N�6ܧ&�S�t}�*]�5�2K�͵���9^�yȪ��?��m���S;��s���8u��=���]~���x��� 0000033585 00000 n The mutual recognition procedure (MRP) is a European authorisation route resulting in a mutually recognised product.Mutual recognition must be used when a product is already authorised in at least one Member State on a national basis and the Marketing Authorisation Holder wishes to obtain a Marketing Authorisation (MA) for the same product in at least one other Member State. 0000004837 00000 n h�b```"1)o� �� @16� �3H���c`�À���q�*�����u�5�&��=5y�!���sD��#׭�����2��.7� h�<6{U���3D\:��* ���c�@H H�m@ ��xH�9XD����C�A%�@>�# 0000006790 00000 n CMDh; EMA Committee for Medicinal Products for Human Use(CHMP) Authorisation procedures - The centralised procedure ; Legal framework governing medicinal … 0000007437 00000 n … 0000039971 00000 n Chronocort is a modified release preparation of hydrocortisone that has been designed to treat a rare condition, congenital adrenal hyperplasia …

H�\��n�@��~�Y&��w� B"��X�G%} �j�ؖ1޾s� *)�7����/�f������?��م�����e�NMp�p����\�5�}��7����q��v��y��l�t��x�2O7��n�Cx���S��?��_�ݳ�w�q�Ρ�]�V+׆c�������i�˶�������{��6W�uI�fh�e�7a����-��Y��G���з��W�ñ����e�.�u���%�jQ�`��X�"��"�+rzfCހ�/��/��/ٲff�̺$���\�kr V���l�5yY�#��r�9�2z�'{0��Ž��Ž�����]�+�+�+�+�(���ѣ���������������������g_���E�2G���Q�(s9ʎ����s3SS&�*�*��s�7��}}�}}����|��ޠ��������lt68� �F���� �Fg�����lt68� ��32���UQ�y!d8/�\�A�OF&N�{�cs��8�i��b��>��� �� endstream endobj 63 0 obj <> endobj 64 0 obj <>stream 0000052642 00000 n 0000015845 00000 n Agency (EMA).

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If none is reached, the procedure is submitted to the appropriate EMA scientific committee (CHMP), for arbitration. 0000010516 00000 n 0000004872 00000 n 0000008709 00000 n 2.01 December 2012 EFPIA Updated text and folder structure graphic, changed EMEA to EMA except for the CP procedure number, If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed.

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0000005184 00000 n 0000043276 00000 n 0000030359 00000 n For medicinal products (that contain new chemical entities and were not yet authorised in the EU/EEA at the time the Regulation 726/2004 came into force) that do not fall under any of the above-mentioned categories, companies can submit an application for a centralised marketing authorisation, provided the medicinal product constitutes a significant therapeutic, scientific or technical innovation, or the product is in any other respect in the interest of patient or animal health. 0000009698 00000 n 0000012820 00000 n The EMA is a decentralised body of the European Union situated in Amsterdam. Application for Marketing Authorisation (MA) ... HMA and CMDh/v are in the process of making appropriate changes to this website. 1.4 August 2009 EMEA Alignment to the New Variation Regulation and Change Requests 1.4.1 November 2011 EMA Alignment to EU M1 v 1.4.1 1.4.2 December 2012 EMA Updated the xml examples contained in the grey areas. 0000014528 00000 n 0000002473 00000 n The opinion of the EMA Committee is then forwarded to the Commission. 0000001960 00000 n In case you notice information that should be updated, please report this website link using the contact form.
A Marketing Authorisation (MA) for a medicinal product intended for the use in all EU/EEA countries may be obtained submitting an application to the European Medicines Agency (EMA) for those products falling within the scope of the centralised procedures (CP). 0000018577 00000 n 0000016911 00000 n H�\��j� ��>�w�ٜ%P�r����NR�eby��6l�*����s���)d�o݀�@�q�;��@�ڂ. 0000004542 00000 n 0000005073 00000 n %PDF-1.7 %���� 0000003187 00000 n H�\�ݎ�0��y Related information. 0000051486 00000 n

Specialty pharmaceutical company, Diurnal, has announced, in an April 1, 2020 press release, that the marketing authorization application (MAA) for Chronocort has passed validation with the European Medicines Agency (EMA). 0000010046 00000 n �+�f0_8ܮ����Bߑw�洝1Tn��8�E��poB��"32�x)KD�;M[��9��f��V�F�����{.�c,�C��A��1BH��8�\ �b�OPS�| �T�U� Ě�U Ә���u[�C�w ��X� endstream endobj 47 0 obj <>>>/Lang(en-GB)/Metadata 44 0 R/Outlines 36 0 R/PageLabels 41 0 R/Pages 43 0 R/Type/Catalog/ViewerPreferences<>>> endobj 48 0 obj <>/ExtGState<>/Font<>/ProcSet[/PDF/Text]/XObject<>>>/Rotate 0/Tabs/W/Thumb 37 0 R/TrimBox[0.0 0.0 595.276 841.89]/Type/Page>> endobj 49 0 obj <> endobj 50 0 obj <> endobj 51 0 obj <> endobj 52 0 obj <> endobj 53 0 obj <> endobj 54 0 obj <>stream 0000001356 00000 n 0000033443 00000 n Regulatory procedure Submitted to EMA from; As part of a marketing authorisation application (MAA) or submitted by a third party in the context of a MAA: 1 January 2015: As part of a procedure under Article 58 of Regulation (EC) No 726/2004 (medicines for use outside the EU) 1 January 2015 : As part of new indication or line extension applications relating to existing … Centralised Procedures. 0000017883 00000 n 0000010944 00000 n 0000004960 00000 n 0000051413 00000 n �ݺ6�-�K=~����i�ˡ����x�5�����+�|E�fh�m��8��%fUa�������b��w?,�N��w=e��=\"vm�6����yY�� Ư�W���5厼��{0�mȪ�$��X�j�W�m0^��`O��� ����#�������������XK@-�$�`��o����o�s���Y�,��s9�A�0G�#��_03%e�.A]�w��CX��Fa���5 trailer <<871A1EF8789A41BF801954722D1C382D>]/Prev 100114>> startxref 0 %%EOF 98 0 obj <>stream 0000020215 00000 n