- Royal Decree 577/2013, in which the pharmacovigilance of medications for human use is regulated; - Order SAS/3470/2009, which publishes guidelines on post-authorisation observational studies for drugs for human use and applicable legislation of the Autonomous Community of Madrid; - Royal Decree01/2015, of 24 July, approving therevised text of theActapprovingguaranteesand rationaluse of medicinesand health products; - of 11 October, regulating the authorisation and registration Royal Decree 1345/2007 procedures and the dispensing conditions for industrially manufactured medicines for human use; - Law 1/1998 of March 2, Foundations of the Community of Madrid. According to Article 23, employers may contract with the Foundation, either on its own behalf or on that of a third party, prior authorisation of the Protectorate of Foundations. - Organic Law 15/99 of 13 December on the protection of personal data and Act 41/2002, of 14 November, governing the Basic Aspects of Patients’ Autonomy. 6. That the SPONSOR has obtained permission fromthe Spanish Agency for Drugs and Health Products (hereinafter AEMPS), of Approval by the “Date AEMPS”, approval from the Clinical Trials Ethics Committee of the Hospital (CREC) of “Name Hospital whose CREC has given approval and on of Approval by the City” “Date and by the Autonomous Community of Madrid of Approval of referred CREC” “Date the and obtained the Consent of HULP Management on of Consent of A.C.M” “Date HULP Management”. Now, therefore, the Parties express their desireto execute this Agreement according to the following: cLAUSES ONE.- OBJECT AND DURATION 1.1. The SPONSOR contracts FIBHULP to perform the study previously cited, which will be performed primarily in the facilities of LA PAZ UNIVERSITY HOSPITAL under the management of the PRINCIPAL INVESTIGATOR according to the regulations specified in the protocol. 1.2.The estimated duration of the research will be ……. Months.
- Royal Decree 577/2013, in which the pharmacovigilance of medications for human use is regulated; - Order SAS/3470/2009, which publishes guidelines on post-authorisation observational studies for drugs for human use and applicable legislation of the Autonomous Community of Madrid; - Royal Decree01/2015, of 24 July, approving therevised text of theActapprovingguaranteesand rationaluse of medicinesand health products; - Royal Decree 1345/2007 of 11 October, regulating the authorisation and registration procedures and the dispensing conditions for industrially manufactured medicines for human use; - Law 1/1998 of March 2, Foundations of the Community of Madrid. According to Article 23, employers may contract with the Foundation, either on its own behalf or on that of a third party, prior authorisation of the Protectorate of Foundations. - Organic Law 15/99 of 13 December on the protection of personal data and Act 41/2002, of 14 November, governing the Basic Aspects of Patients’ Autonomy. 6. That the SPONSOR has obtained permission fromthe Spanish Agency for Drugs and Health Products (hereinafter AEMPS), “Date of Approval by the AEMPS”, approval from the Clinical Trials Ethics Committee (CREC) of the Hospital “Name of Hospital whose CREC has given approval and City” on “Date of Approval by the referred CREC” and by the Autonomous Community of Madrid “Date of Approval of the A.C.M” and obtained the Consent of HULP Management on “Date of Consent of HULP Management”. Now, therefore, the Parties express their desireto execute this Agreement according to the following: cLAUSES ONE.- OBJECT AND DURATION 1.1. The SPONSOR contracts FIBHULP to perform the study previously cited, which will be performed primarily in the facilities of LA PAZ UNIVERSITY HOSPITAL under the management of the PRINCIPAL INVESTIGATOR according to the regulations specified in the protocol. 1.2.The estimated duration of the research will be ……. Months.
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