The aim of studying and bibliography

The main aim of study: Preparing students for active participation in the procedure of registration of medicinal products. Creating registration documentation, planning work related to the registration of medicinal products

The general information about the module: Registration for semester 7

Bibliography required to complete the module

Bibliography used during lectures

1		Ustawa – Prawo farmaceutyczne	.
2		Rozporządzenie w sprawie wymagań Dobrej Praktyki Wytwarzania	.
3		Rozporządzenie w sprawie wzoru wniosku o wydanie pozwolenia na dopuszczenie do obrotu produktu leczniczego	.
4		Rozporządzenie w sprawie szczegółowego sposobu przedstawiania dokumentacji dołączanej do wniosku o dopuszczenie do obrotu produktu leczniczego	.
5		Rozporządzenie w sprawie dokonywania zmian w pozwoleniu i dokumentacji dotyczącej wprowadzania do obrotu produktu leczniczego	.
6		Dyrektywa 2001/83/WE Parlamentu Europejskiego i Rady w sprawie wspólnotowego kodeksu odnoszącego się do produktów leczniczych stosowanych u ludz	.
7		Notice to Applicants, Volume 2A Procedures for Marketing Authorizations, Chapter 1 Marketing Authorizations	.
8		Farmakopea Europejska	.
9		urpl.gov.pl	.
10		ec.europa.eu/health/documents/eudralex/	.
11		ema.europa.eu	.
12		ich.org	.
13		edqm.eu	.

Basic requirements in category knowledge/skills/social competences

Formal requirements: General knowledge about GMP

Basic requirements in category knowledge: Passed the GMP

Basic requirements in category skills: No requirements

Basic requirements in category social competences: No requirements

Module outcomes

MEK	The student who completed the module	Types of classes / teaching methods leading to achieving a given outcome of teaching	Methods of verifying every mentioned outcome of teaching	Relationships with KEK	Relationships with PRK
01	He knows how to prepare a registration application for a medicinal product	lecture	pass the part oral	K_W11+ K_U13+ K_K01+	P6S_KK P6S_UW P6S_WK
02	He knows the structure of the registration application	lecture	pass oral part	K_W11+ K_U13+ K_K01+	P6S_KK P6S_UW P6S_WK
03	He can make changes to the registration application	lecture	pass the oral part	K_W11+	P6S_WK

Attention: Depending on the epidemic situation, verification of the achieved learning outcomes specified in the study program, in particular credits and examinations at the end of specific classes, can be implemented remotely (real-time meetings).

The syllabus of the module

Sem.	TK	The content	realized in	MEK
7	TK01	Type of application for admission of a medicinal product to the market - full application; equivalent to a reference medicinal product; a medicinal product containing a well-established medicinal substance (WEU); a combined medicinal product containing a mixture of known active substances appearing in authorized medicinal products not yet used in the specified composition for medicinal purposes; traditional herbal medicinal product, homeopathic medicinal product.	W01-W02	MEK01 MEK02
7	TK02	Registration procedure; Central procedure, mutual recognition procedure, decentralized procedure, national procedure	W03-W04	MEK01
7	TK03	Documentation attached to applications (CTD) - Structure, format, content	W05-W06	MEK01 MEK02
7	TK04	Module 3 Quality: Active substance (nomenclature, structure, preparation, characterization, control of the active substance, standards or reference materials, immediate packaging and closure system, stability); Medicinal product (description and composition of the medicinal product, developmental studies on the medicinal product, manufacture, control of excipients , control of the medicinal product, reference standards or materials, immediate packaging and closure system, durability, production facilities and equipment, regional information);	W07-W08	MEK02
7	TK05	Laboratory and registration series Development of the composition and technology (development works), creation of registration series (series size, validation), series control and validation of test methods, durability tests. Making changes to the registration dossier	W09-W10	MEK01 MEK02 MEK03

The student's effort

The type of classes	The work before classes	The participation in classes	The work after classes
Lecture (sem. 7)		contact hours: 10.00 hours/sem.	complementing/reading through notes: 3.00 hours/sem.
Advice (sem. 7)
Credit (sem. 7)	The preparation for a Credit: 15.00 hours/sem.	The oral credit: 1.00 hours/sem.

The way of giving the component module grades and the final grade

The type of classes	The way of giving the final grade
Lecture	Oral test before the committee
The final grade	Grade from the lecture

Sample problems

Required during the exam/when receiving the credit
(-)

Realized during classes/laboratories/projects
(-)

Others
(-)

Can a student use any teaching aids during the exam/when receiving the credit : no

The contents of the module are associated with the research profile: no