The theme of the lesson: Examples of accompanying letter
The aim of the lesson:
Алған білімдерін кеңейтіп, қызығушылығын арттыру.
Ойлау, көру, сезіну қабілетін дамыту
Әрбір істі саналы түрде орындауға тәрбиелеу.
Methods of the lesson: question-answer, group work, individual work.
Type of the lesson: new theme
Plan of the lesson:
І Organization moment.
II Correct homework.
III New theme.
IV Home work
Procedure of the lesson:
I Organization moment:
Who is on duty today?
What is the date today?
what is the day today?
What is the weather like today?
What season is it now?
II Correct homework.
III Warm up
1. Read the text
what contents should be in the accompanying letter?
All applications must be accompanied by a cover letter. This is not only valid for new applications, but also for correspondence rounds, variations, PSURs etc.
We urge you to discuss different subjects in separate letters. One subject per letter.
This means that separate letters should accompany even PSURs relating to different active ingredients.
In order to speed up the application process, please mention the following details – where applicable – in the heading of your cover letter (preferably in the order shown):
The names of all products to which your letter refers, and the associated RVG numbers or EU licence numbers of the products that are registered via the Centralised procedure;
Case number (if available);
Date of our letter to which you are responding;
Type of procedure (National/Mutual Recognition/Decentralised/Centralised) with -where applicable- associated procedure number;
Whether or not preliminary to a MRP with the Netherlands as RMS;
E-mail address contact person;
Brief description of the subject of your letter.
The cover letter of an electronic dossier must contain the following additional information:
The number of CD(s) or DVD(s) for the complete dossier;
A statement that the content of the electronically submitted information is identical to that of the corresponding parts as hard copy;
A statement that the submission has been checked with an up-to-date virus scanner;
A statement that the application has been structured in accordance with the ICH Granularity Document;
A list of the content of the CD(s) or DVD(s).
IV Home work. To make a letter