Date:
The theme of
the lesson: Examples of
accompanying letter
Form: 11th
The aim of
the lesson:
1.
Алған білімдерін кеңейтіп,
қызығушылығын арттыру.
2.
Ойлау, көру, сезіну қабілетін
дамыту
3.
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
V Marks
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.
Contents
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
V Marks.
Оставьте свой комментарий
Авторизуйтесь, чтобы задавать вопросы.