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Practical Pharmacy and Pharmaceutical Legislation

Study Course Description

Course Description Statuss:Approved
Course Description Version:1.00
Study Course Accepted:21.03.2024 09:49:27
Study Course Information
Course Code:ZFTK_062LQF level:Level 7
Credit Points:5.33ECTS:8.00
Branch of Science:Basic Sciences of Medicine, including Pharmacy; Social PharmacyTarget Audience:Pharmacy
Study Course Supervisor
Course Supervisor:Nora Krauja
Study Course Implementer
Structural Unit:Department of Applied Pharmacy
The Head of Structural Unit:
Contacts:Riga, 16 Dzirciema Street, zftkatrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)10Lecture Length (academic hours)2Total Contact Hours of Lectures20
Classes (count)15Class Length (academic hours)2Total Contact Hours of Classes30
Total Contact Hours50
Full-Time - Semester No.2
Lectures (count)7Lecture Length (academic hours)2Total Contact Hours of Lectures14
Classes (count)9Class Length (academic hours)2Total Contact Hours of Classes18
Total Contact Hours32
Study course description
Preliminary Knowledge:
Pharmaceutical chemistry, pharmacognosy, pharmaceutical and industrial dosage form technology, pharmacology, economics, information technology.
Objective:
1. To get acquainted with the duties and tasks of a pharmacist regulated in the pharmaceutical legislation of Latvia and the European Union, in pharmaceutical companies (FDU) and their supervision authorities; the organisation of company activities, the tax system, the basics of company financing, the basic principles of accounting and economic activity analysis at FDU. 2. To acquire theoretical knowledge of the main legislative enactments in the pharmaceutical industry. 3. To develop skills in the practical application of regulatory acts in the operation of companies.
Topic Layout (Full-Time)
No.TopicType of ImplementationNumberVenue
1Pharmaceutical Law, terminology. Procedures for opening and operating pharmacies. Licensing terms. Regulations for storing medicinal products in pharmacies. Classification of medicinal products as prescription and non-prescription medicinal products. Regulations for pricing medicinal products.Lectures2.00auditorium
Classes1.00auditorium
2Regulations on the distribution of prescription medicinal products. Procedure for distribution of narcotic and psychotropic drugs. Treatment courses. Prescription expiration dates and storage time in the pharmacy.Lectures1.00auditorium
Classes2.00auditorium
3Procedure of the reimbursement for the acquisition of medicinal products. Medicinal product wholesalers. Good distribution practice of medicinal products.Lectures1.00auditorium
Classes1.00auditorium
4Preparation of medicinal products in the pharmacy, control of prepared medicinal products. Regulations on labelling of medicinal products. Distribution of industrially produced medicinal products in a pharmacy. Procedure for the circulation of alcohol.Lectures1.00auditorium
Classes3.00auditorium
5Procedure of the distribution and quality control of medicinal products. Requirements for import and export of medicinal products. Health Inspectorate, State Agency of Medicines, functions and rights thereof.Lectures1.00auditorium
Classes1.00other
6Pharmaceutical manufacturing companies, structure and functions thereof. Qualification requirements for personnel. Procedure for opening and licensing a pharmaceutical manufacturing company. Medicinal product quality assurance system in manufacturing companies.Lectures1.00auditorium
Classes0.00auditorium
7Management of pharmaceutical companies. Responsibilities and functions of a pharmacy manager. Company management methods. Qualification requirements for pharmaceutical personnel.Lectures1.00auditorium
Classes3.00auditorium
9Record-keeping as a method of information collection and work organisation in companies and administrative institutions. Documents, classification thereof. Document handling. Archive. Personnel documents.Lectures0.00auditorium
Classes1.00auditorium
10Occupational protection in a company. Establishment of the organisational structure of occupational protection.Lectures1.00auditorium
11International organisations whose activities affect the field of pharmacy. The European Union, its institutions, legal system, decision-making, budget and structural measures.Lectures1.00auditorium
Classes0.00auditorium
12The role of government in the market economy. Characterisation of the pharmacy market. Business objectives, basic principles, process elements. Starting a business and the process of company functioning. Possibilities of commercialisation of innovative ideas.Lectures1.00auditorium
Classes1.00auditorium
13National fiscal and tax policy, impact thereof on other governmental policies. State taxes applicable in the Republic of Latvia. Detailed description of individual taxes, elements thereof, administration and use for purposes.Lectures1.00auditorium
Classes2.00auditorium
14Financial accounting in the company, tasks, basic principles and types thereof, as well as groups of accounting objects. Accounting and organisation thereof. Accounting documents, groups thereof, requirements for documents. Bookkeeping accounts.Lectures1.00auditorium
Classes1.00auditorium
15Annual statement, objectives, stages and deadlines for the preparation thereof. Inventory procedure. Structure of the annual statement: financial statement and management report. Financial statement documents, characteristics, principles of preparation thereof.Lectures1.00auditorium
Classes2.00auditorium
16Financial analysis, objectives and tasks thereof. Internal and external financial analysis. Methods of financial analysis. Financial planning and demand forecasting.Lectures0.00auditorium
Classes2.00auditorium
17Determination of costs and revenue. Classification of costs, alternative costs. Cost and price calculation in the company’s activities. Company financing, types and sources thereof. Financing with equity and borrowed capital.Lectures1.00auditorium
Classes2.00auditorium
18Investments, characteristics thereof and evaluation of economic efficiency. Business plan of a company. Fundamentals of marketing. Identification of consumer needs and product promotion measures. Fundamentals of project management.Lectures1.00auditorium
Classes1.00auditorium
19Pharmacoeconomic evaluation, possibilities for the application thereof. Analytical methods used in pharmacoeconomic evaluation, characterisation thereof.Lectures1.00auditorium
Classes1.00auditorium
Assessment
Unaided Work:
Work with relevant literature, practical work with searching and collecting information, preparing a presentation on a specific topic.
Assessment Criteria:
Independent and practical assignments, presentation, oral exam. The overall assessment of the course will consist of the semester test and exam grades. Exam – final examination at the end of the study course to obtain an assessment for the learning outcomes achieved. Exam results will be assessed on a 10-point scale. The assessment consists of the cumulative assessment of the grades obtained during the semester for the colloquia (50%) and the performance of the tasks of the final examination (50%).
Final Examination (Full-Time):Exam (Oral)
Final Examination (Part-Time):
Learning Outcomes
Knowledge:As a result of completing the study course, students will be able to explain the functions of a pharmacist in pharmaceutical companies and their supervision authorities, in accordance with the legislative requirements of Latvia and the European Union, as well as be able to evaluate the results of the company’s economic activity.
Skills:As a result of completing the study course, students will be able to apply legislative enactments, fulfilling the duties of a pharmacist in pharmaceutical companies and organise the documentation of economic activity in pharmacies.
Competencies:Will be able to organise the day-to-day operational activities of pharmaceutical companies, in accordance with legislative requirements, assess discrepancies in the actual daily work processes.
Bibliography
No.Reference
Required Reading
1Farmācijas likums. Pieejams no: https://likumi.lv/doc.php?id=43127
2Likums "Par narkotisko un psihotropo vielu un zāļu likumīgās aprites kārtību". Pieejams no: https://likumi.lv/doc.php?id=40283
3Likums "Par prekursoriem". Pieejams no: https://likumi.lv/doc.php?id=40284
4Ministru kabineta 2006.gada 18.aprīļa noteikumi Nr.304 «Noteikumi par zāļu ražošanas un kontroles kārtību, par zāļu ražošanu atbildīgās amatpersonas kvalifikācijas prasībām un profesionālo pieredzi un kārtību, kādā zāļu ražošanas uzņēmumam izsniedz l
5Ministru kabineta 2006.gada 9.maija noteikumi Nr.376 «Zāļu reģistrēšanas kārtība»
6Ministru kabineta 2005.gada 22.novembra noteikumi Nr.885 «Zāļu klasifikācijas kārtība»
7Ministru kabineta 2006.gada 17.janvāra noteikumi Nr.57 «Noteikumi par zāļu marķēšanas kārtību un zāļu lietošanas instrukcijai izvirzāmajām prasībām»
8Ministru kabineta 2013.gada 22.janvāra noteikumi Nr.47 «Farmakovigilances kārtība»
9Ministru kabineta 2007.gada 26.jūnija noteikumi Nr.416 «Zāļu izplatīšanas un kvalitātes kontroles kārtība»
10Ministru kabineta 2007.gada 26.jūnija noteikumi Nr.436 «Zāļu ievešanas un izvešanas kārtība»
11Ministru kabineta 2005.gada 25.oktobra noteikumi Nr.803 «Noteikumi par zāļu cenu veidošanas principiem»
12Ministru kabineta 2006.gada 31.oktobra noteikumi Nr.899 «Ambulatorajai ārstēšanai paredzēto zāļu un medicīnisko ierīču iegādes izdevumu kompensācijas kārtība»
13Ministru kabineta 2011.gada 17.maija noteikumi Nr.378 «Zāļu reklamēšanas kārtība un kārtība, kādā zāļu ražotājs ir tiesīgs nodot ārstiem bezmaksas zāļu paraugus»
14Ministru kabineta 2008.gada 17.jūnija noteikumi Nr.441 «Narkotisko un psihotropo vielu un zāļu iepirkšanas, saņemšanas, uzglabāšanas, izplatīšanas, izsniegšanas, uzskaites un iznīcināšanas kārtība zāļu un veterināro zāļu ražošanā, zāļu un veterināro
15Ministru kabineta 2007.gada 27.marta noteikumi Nr.220 «Zāļu iegādes, uzglabāšanas, izlietošanas, uzskaites un iznīcināšanas kārtība ārstniecības iestādēs un sociālās aprūpes institūcijās»
16Ministru kabineta 2011.gada 19.oktobra noteikumi Nr.800 «Farmaceitiskās darbības licencēšanas kārtība»
17Ministru kabineta 2010.gada 23.marta noteikumi Nr.288 «Aptieku darbības noteikumi»
18Ministru kabineta 2011.gada 2.augusta noteikumi Nr.610 «Aptieku un aptieku filiāļu izvietojuma kritēriji»
19Ministru kabineta 2004.gada 27.aprīļa noteikumi Nr.454 «Farmaceitu un farmaceitu asistentu reģistrēšanas kārtība»
20Ministru kabineta 2010.gada 23.marta noteikumi Nr.290 «Farmaceitu profesionālās kvalifikācijas sertifikātu izsniegšanas, pārreģistrēšanas un anulēšanas kārtība»
21Ministru kabineta 2005.gada 8.marta noteikumi Nr.175 «Recepšu veidlapu izgatavošanas un uzglabāšanas, kā arī recepšu izrakstīšanas un uzglabāšanas noteikumi»
22ES likumdošana
23 Latvijas Republikas likums ”Likums par budžetu un finanšu vadību”
24Latvijas Republikas likums ”Par nodokļiem un nodevām”
25Latvijas Republikas likums ”Par iedzīvotāju ienākuma nodokli”
26Latvijas Republikas likums ”Par uzņēmumu ienākuma nodokli”
27Latvijas Republikas likums ”Mikrouzņēmumu nodokļa likums”
28Latvijas Republikas likums ”Pievienotās vērtības nodokļa likums”
29Latvijas Republikas likums ”Par valsts sociālo apdrošināšanu”
30Latvijas Republikas likums ”Par maternitātes un slimības apdrošināšanu”
31Latvijas Republikas likums ”Valsts sociālo pabalstu likums”
32 Ministru kabineta 05.01.2016. noteikumi Nr.1 ”Noteikumi par neapliekamā minimuma un nodokļa atvieglojuma apmēru iedzīvotāju ienākuma nodokļa aprēķināšanai”
33Ministru kabineta 08.04.1997. noteikumi Nr.138 ”Noteikumi par iedzīvotāju ienākuma nodokļa papildu atvieglojumiem invalīdiem, politiski represētajām personām un nacionālās pretošanās kustības dalībniekiem”
34Ministru kabineta 15.01.2013. noteikumi Nr.40 ”Noteikumi par pievienotās vērtības nodokļa deklarācijām”
35Ministru kabineta 22.12.2009. noteikumi Nr.1546 ”Noteikumi par bērna piedzimšanas pabalsta piešķiršanas un izmaksāšanas kārtību”
36Ministru kabineta 22.12.2009. noteikumi Nr.1609 ”Noteikumi par bērna kopšanas pabalsta un piemaksas pie bērna kopšanas pabalsta un vecāku pabalsta par dvīņiem vai vairākiem vienās dzemdībās dzimušiem bērniem apmēru, tā pārskatīšanas kārtību un pabals
37Latvijas Republikas likums ”Komerclikums”
38Latvijas Administratīvo pārkāpumu kodekss
39Latvijas Republikas likums ”Par grāmatvedību”
40Ministru kabineta 2003.gada 21.oktobra noteikumi Nr.585 ”Noteikumi par grāmatvedības kārtošanu un organizāciju”
41Ministru kabineta 2003.gada 21.oktobra noteikumi Nr.584 ”Kases operāciju uzskaites noteikumi”
42Latvijas Republikas likums ”Gada pārskatu un konsolidēto gada pārskatu likums”
43Ārvalstu studentiem/For international students
44Pharmaceutical Law
45Body of European Union legislation
46Commercial Law
Additional Reading
1Ministru kabineta 2010.gada 23.martā noteikumi Nr.289 «Noteikumi par zāļu klīniskās izpētes un lietošanas novērojumu veikšanas kārtību, pētāmo zāļu marķēšanu un kārtību, kādā tiek vērtēta zāļu klīniskās izpētes atbilstība labas klīniskās prakses pras