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3CN PEPTIDES
Agence Nationale de Securite du Medicament et des Produits de Sante (ANSM) 143-147 bd Anatole France FR-93285 Saint Denis Cedex France
Copy to Regulatory Affairs Welding GmbH & Co. KG
Ref: Letter of Access to ASMF for Teriparatide (eCTD-PTH).
Number of Active Substance Master File: unknown Name of Active Substance: Teriparatide
29th January 2019
Active Substance Master File holder: BCN Peptides S.A. [Address: Pol. Ind. Eis Vinyets-Els Fogars II, 08777, Sant Quintf de Mediona, Barcelona (Spain)]
To whom it may concern:
The aforementioned Active Substance Master File holder hereby authorises the Agence Nationale de Securite du Medicament et des Produits de Sante to refer to and review the above mentioned Active Substance Master File in support of the following Marketing Authorisation Application(s) or Marketing Authorisation Variation(s) submitted by Welding GmbH & Co. KG:
• Products:
Teriparatide 20 µg/ 80µ1 Solution for injection in pre-filled pen (DE/H/6160/001/DC)
• Marketing Authorisation Holder: Welding GmbH & Co. KG, [Esplanade 39, 20354 Hamburg, Germany]
The aforementioned Active Substance Master File holder commits to ensure batch to batch consistency and to inform Welding GmbH & Co. KG, and Competent Authority of any change in the Active Substance Master File likely to alter in any way the quality and/or safety of products.
The aforementioned Active Substance Master File holder hereby is informed of and accepts that the EEA National Competent Authorities, the EMA including all CHMP and CVMP Members and their experts, and the Certification of Substances Division of the European Directorate for the Quality of Medicines & Healthcare may share the assessment reports of the above mentioned Active Substance Master File amongst themselves.
Please be so kind as to acknowledge receipt.
Sincere}v yoll{s.
Silvia~
Regulatory Affairs BCN Peptides S.A.
Pol. Ind. Eis Vinyets-Els Fogars, II
08777, Sant Quintf de Mediona, Barcelona (Spain) sarrastia@bcnpeptides.com
www.bcnpeptides.com . Tel. +34 938 191 399 . Fax +34 938 264 909 . Pol. Ind. Eis V1nyets-Els Fogars II . 08777 Sant Ouinti de Mediona lBarcelonaJ · SPAIN
