Legislation and Regulatory Affairs of Medicinal Products

Code:

MI075179

Acronym:

LRM

Keywords
Classification	Keyword
OFICIAL	Social Science

Instance: 2025/2026 - 1S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	176	MICF - Transition Study Plan 2023/24 - 2024/25 - 2025/26	5	-	4,5	39	121,5

Teaching language

Portuguese

Objectives

To Understand why medicines must  be authorized and the design of the marketing authorization system.

To Know the terminology and concepts used at national and European level in the area of drug law and regulation, namely in pharmaceutical development,  and validation of methods and processes.

To Know and understand the regulation of aspects associated with the material flows, preparation and control of medicinal products for human or veterinary use, as well as with the evaluation of stability and definition of shelf life.

 

Learning outcomes and competences

Prepare pharmacists  to understand and participate in the preparation of a marketing authorization application for a medicinal product, particularly CTD module 3.

Transversal competencies:

-cognitive: analytical and critical skills;

-methodological: time management, planning skills and digital skills;

-social: interpersonal communication and teamwork.

Working method

Presencial

Program

The regulatory framework in the area of medicines.
Main historical elements in European and North American context.
The construction of a global system and the ICH. 

The Regulatory System of the medicinal product in the European Union.
Legal aspects of the marketing authorisation of human medicines the European coordination of regulatory authorities and the freedom of movement.
The Europeean Pharmacopeia, the Portuguese Pharmacopeia and other publications. 

The Markrting  authorisation.
National, centralised, decentralised and mutual recognition procedures. 
European and national portals for submission of Marketing authorisation

The common technical document (CTD).
The importance of DMF and CEP in assessing the quality of the drug substance.

Variations of the  terms of a marketing authorisation

The European system and its operationalization:
EMA;
The functioning of the CHMP and several CXMP.

Discovery and development of medicine.
Quality. Preclinical safety and clinical efficacy and safety.
The European regulations in the field of medicine:legal aspects of manufacturing of human medicines. Good manufacturing practices.

Mandatory literature

Estado; Decreto-Lei 176/2006, 2006
EMA; EMA Scientifig guidelines
ICH; ICH guidelines

Complementary Bibliography

Abel Mesquita; Direito farmacêutico anotado. ISBN: 972-98579-2-X
António Celestino do Carmo Cavaco; A^construção da Europa do medicamento: um desafio do mercado único
José Aranda da Silva; Saúde pública, farmacêuticos e medicamentos. ISBN: 978-972-8610-60-9
Maria Francisca Côrte-Real Magalhães e Menezes; Ciclo de vida do medicamento

Teaching methods and learning activities

Theoretical classes (2h/week): essentially the expository and interrogative method, using PowerPoint presentations, where discussion and interaction with students are promoted.
Theoretical-practical classes (2h/week) will be aimed at the elaboration, presentation and discussion of a work related to the syllabus contents of the theoretical classes, promoting the interrelation of knowledge and the critical spirit of the students.

The teacher in charge is available for the attendance of students by appointment.

keywords

Health sciences > Pharmacological sciences > Pharmacy

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	65,00
Trabalho escrito	35,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	56,00
Frequência das aulas	39,00
Trabalho escrito	20,00
Apresentação/discussão de um trabalho científico	6,00
Total:	121,00

Eligibility for exams

Calculation formula of final grade

The final grade is weighted as follows: 65% - written test + 35% - theoretical-practical group work with presentation and discussion.
Students with final scores equal to or greater than 9.5 values are considered approved. 
Students with final scores less than 9.5 values are considered not approved.

Special assessment (TE, DA, ...)

Students who for special reasons contemplated in the regulations are not evaluated in the distributed component will be assessed by exam, without prejudice to compliance with applicable special legislation.

Classification improvement

At the time of appeal, it is only possible to improve the classification of the theoretical component, requiring registration in academic services for this purpose.
The improvement in the group work component (theoretical-practical) can only occur by the new frequency of the Course Unit. Improvement in the final exam of this component of the distributed evaluation is not allowed.

Observations

Two mobility students with fluency in Portuguese or Castilian are accepted