Spring Intro 2023

Jenny Lamport

 Trade name  Qualitative and quantitative composition  Pharmaceutical form  Clinical particulars ● Indications, dosage & administration, contraindications, warnings & precautions, interactions, pregnancy & lactation, effects on ability to drive, side effects, overdose  Pharmacological properties ● Pharmacodynamics, pharmacokinetics, preclinical safety data  Pharmaceutical particulars ● Excipients, incompatibilities, shelf life, storage precautions, container, instructions for use  MA holder and number  Date of first authorisation/renewal  Date of revision of text Summary of product characteristics

The Organisation for Professionals in Regulatory Affairs

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Expert declaration (Module 1.4)

Information about the expert ● According to his/her respective qualifications the undersigned expert declares hereby to have performed the duties set out in Article 12 and in accordance with Annex I Part I 1.4 of Directive 2001/83/EC as amended ● Name and address of expert: – Address: – Date: – Signature: – Brief information about the educational background, training and occupational experience

The Organisation for Professionals in Regulatory Affairs

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