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Registration of medicines


Some basic information about the module

Cycle of education:
2022/2023
The name of the faculty organization unit:
The faculty Chemistry
The name of the field of study:
Pharmaceutical engineering
The area of study:
technical/biological sciences
The profile of studing:
The level of study:
first degree study
Type of study:
full time
discipline specialities :
The degree after graduating from university:
Bachelor of Science (BSc)
The name of the module department :
Faculty of Chemistry
The code of the module:
12732
The module status:
mandatory for teaching programme
The position in the studies teaching programme:
sem: 7 / W10 / 1 ECTS / Z
The language of the lecture:
Polish
The name of the coordinator 1:
Dziekanat WCH Administracyjnie,
The name of the coordinator 2:
Agnieszka Bukowska, DSc, PhD, Eng.

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
MEK01 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
MEK02 He knows the structure of the registration application lecture pass oral part K-W11+
K-U13+
K-K01+
 P6S-KK
P6S-UW
P6S-WK
MEK03 He can make changes to the registration application lecture pass the oral part K-W11+
 P6S-WK

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