DELEGATED LEGISLATION

INTRODUCTION

The topic of delegated legislation has been a hot topic in legal theory because of its many implications. Different stances on the matter have resulted from scholars’ constant presentation of divergent, even contradicting, opinions regarding the delegation of legislative power. Despite the fact that delegated legislation is a common practice and nearly a standard in modern times, opinions differ. For instance, Cooley harshly criticised delegation’s power. He stated: “That section cannot transfer the authority granted to the parliament to any other body or authority. This is one of the established principles of constitutional law.”
The State’s sovereign power must stay in place wherever it has invested its power, and until the constitution is changed, the constitutional authority is the only one allowed to enact laws. By selecting other bodies to which the power is handed, the power in whose hands this high privilege is entrusted cannot escape responsibility, nor can it take the place of any other body’s judgement, wisdom, and patriotism. those that only the people believe are worthy of receiving that sovereign trust. “No legislative body, or any other body of authority, either in general or in the state, especially when making laws,” he added, “can delegate power to another department of government?” The presence of its powers provides the explanation. That great privilege is entrusted to his patriotism, wisdom, and judgement, and no one else. He acts beyond his authority when he agrees to assign the trust rather than use it himself.

Delegated legislation and administrative legislation are terms used to describe the authority granted by the legislature to an administrative body to enact rules, regulations, and orders on specific subjects. It might be characterised as the executive or administrative branch’s legislative authority. For short, this is known as delegated legislation. The term “legislative outsourcing” has also been used.
HISTORY OF DELEGATED LEGISLATION
In constitutional concerns, the Privy Council served as India’s highest court of appeal until 1949. In the well-known case of R. v. Burah1, the Privy Council was asked to rule on the constitutionality issue. An Act was passed by the Indian legislature in 1869 to remove the Garo Hills from Bengal’s civil and criminal jurisdiction. This act also gave the PMVCs of Bengal’s civil and criminal jurisdiction authority to an official chosen by the Bengal governor. According to Section 9 of the Act, the Lieutenant Governor was also permitted to apply any of its provisions to the Khasi and Jaintia hills with incidental modifications. Because the Indian legislature is a delegate of the British Parliament, it cannot further delegate, according to the Calcutta High Court, which ruled that Section 9 of the Indian legislature’s legislative power delegation was illegal. On appeal, the Privy Council overturned the Calcutta High Court’s ruling and maintained Section 9’s validity, arguing that it is only a conditional law. There were two interpretations of the Privy Council’s decision. According to one interpretation, the delegation of legislative responsibilities is unrestricted because the Indian legislature is not a representative of the British Parliament. According to the other interpretation it was argued that since the Privy Council has validated only conditional legislation, therefore delegation of legislative power is not permissible.

In Jatindra Nath Gupta v. Province of Bihar2, the Federal Court considered whether the transfer of legislative functions was legitimate. The constitutionality of Section 1(3) of the Bihar Maintenance of Public Order Act, 1948, was contested in this case on the grounds that it gave the provincial administration the authority to prolong the Act’s existence for an additional year with any changes it saw suitable. Because it is a fundamental legislative act, the Federal Court ruled that the power of extension with modifications is an illegal delcgation of legislative power. In this way, it was established for the first time that legislative authority could not be delegated in India. But according to Fazal Ali’s dissenting view, the transfer of authority. However, Fazal Ali, in his dissenting opinion held that the delegation of the power of extension of the Act is constitutional because according him it merely amounted to a continuation of the Act.

The ruling in the Jatindra Nath case (above) raised questions regarding the boundaries of legislative power delegation. The President of India therefore requested the Court’s opinion under Article 143 of the Constitution regarding the constitutionality of three Acts covering three different periods: (i) Section 7 of the Delhi Laws Act, 1912, (ii) Section 2 of the Ajmer
Merwara (Extension of Laws) Act, 1947, and (iii) Section 2 of the Part ‘C” States (Laws) Act, 1950, in order to clarify the legal position for the legislature’s future guidance in matters of delegation of legislative functions. Section 7 of the Delhi Laws Act, 1972, 3gave the province administration the authority to apply any law that was in effect in any region of British India to the Delhi area with some limitations and modifications. The government was given the authority to extend any legislation that was in effect in another province to the province of Ajmer-Merwara with any necessary modifications and restrictions by Section 2 of the Ajmer
Merwara (Extension of Laws) Act, 1947. Section 2 of the Part ‘C’ States (Laws) Act, 1950 gave the Central Government the authority to apply any law that was in effect in any Part ‘A’ State to Part ‘C’ States with the modifications and restrictions it sees fit.

The Delhi Laws Act 4is regarded as the delegated law equivalent of the Bible. The case was heard by seven judges, who issued seven different rulings. There were two extreme stances taken in the argument. Mr. M.C. Setalvad maintained that the authority to delegate comes with the capacity to enact laws, and that this authority is unrestricted unless the legislature has fully renounced or effaced itself. In order to demonstrate to the court that there is an implicit ban on the delegation of legislative functions, the learnt counsel based his arguments on the theories of separation of powers and “delegatus non potest delegare”.

SCOPE OF DELEGATED LEGISLATION

To avoid threats, the parliament strictly limits the scope of delegation, providing adequate safeguards, control, and appeals against executive orders and decisions. The powers transferred to the executive to change the provisions of the law by order must remain within the framework of the authorized law. The power to make such an amendment undoubtedly involves some discretion, but it is exercised in furtherance of the legislative policy of the Act and i) cannot override or
ii) be inconsistent with the legislative policy of the Act or
iii) change the essential features, identity, structure, or policy of the Act.

Articles 245 and 246 of the Constitution of India 5provide that Parliament and State legislatures exercise legislative power. Delegation of legislative power is considered inevitable and therefore not prohibited in the Constitution.

Additionally, Article 13 (3) (a) 6of the Constitution of India provides that the Act includes all ordinances, regulatory rules, regulations, notifications, etc., which are declared void as a violation of fundamental rights. In addition, the courts made several legal decisions in which they justified delegated legislation.

Commenting on the need for delegated legislation, Justice Krishna Iyer in Arvinder Singh Vs. The State of Punjab 7has rightly observed that the complexities of modern administration are so confusing and full of detail, urgency, difficulty, and need for flexibility that our great legislature may not begin when it is necessary to deal directly and comprehensively with legislative activities in their abundance, rise, and decay. Delegating part of the legislative power becomes essential for viability.

TYPES OF DELEGATION OF LEGISLATIVE POWER IN INDIA

Delegated legislation can be categorized based on several factors:

1. TITLE-BASED CLASSIFICATION: This classification depends on the titles given to different legislative provisions authorized by an Act. These provisions can take various forms such as regulations, rules, by-laws, orders, or directions.: Title-based classification is a foundational concept in legal systems worldwide, vital for understanding the organization and hierarchy of laws within a jurisdiction. This system categorizes laws based on their hierarchical status and authority. Here’s a comprehensive explanation:

a. Primary Legislation: This represents the highest level of law within a legal system, often referred to as statutes, acts, or constitutions. Primary legislation is typically enacted by the legislative body of a country or state, such as a parliament or congress. It establishes fundamental principles and sets the framework for governance. Primary legislation addresses broad legal issues and typically requires a formal legislative process for enactment, including debates, voting, and approval by the designated authority.

b. Secondary Legislation: Also known as subordinate legislation or delegated legislation, this derives its authority from primary legislation. It is created by government agencies, ministers, or other executive bodies authorized by primary legislation to elaborate on the broader policy objectives set out in the primary laws. Secondary legislation deals with specific administrative and technical matters, such as regulations, orders, and bylaws. Unlike primary legislation, secondary legislation isn’t enacted through the same formal legislative process but is instead delegated by the legislature to executive authorities.

c. Tertiary Legislation: Some legal systems also recognize tertiary legislation, which includes administrative guidelines, circulars, or policy documents issued by government agencies or departments. While not legally binding like primary or secondary legislation, tertiary legislation provides guidance on interpreting and implementing laws and regulations. It ensures consistency and uniformity in the application of legal principles and administrative procedures.Title-based classification is crucial for maintaining order and coherence within a legal system, clarifying the sources of law, and delineating the respective roles and powers of legislative and executive authorities. It enables legal professionals, policymakers, and citizens to navigate the complexities of the law and understand the legal framework governing their rights and obligations. Additionally, title-based classification facilitates the identification of legal norms applicable to specific situations and ensures accountability and compliance with legal requirements.

2. DISCRETION-BASED CLASSIFICATION (CONDITIONAL LEGISLATION)

This classification is based on the discretion vested in the rule-making authority. It divides administrative rule-making into subordinate and contingent or conditional legislation. Discretion-based classification in delegated legislation pertains to the extent of authority vested in administrative bodies when formulating regulations under the mandate of primary legislation. Delegated legislation, also known as subordinate or secondary legislation, empowers government agencies, ministers, or other authorized entities to elaborate on the broader policy objectives outlined in primary laws.
Here’s how discretion-based classification applies to delegated legislation:

a. Mandatory Delegated Rules: Some primary legislation may impose specific criteria or guidelines that restrict the discretion of administrative bodies in formulating delegated legislation. These rules function similarly to mandatory directives, setting forth clear requirements or standards that must be adhered to in the exercise of delegated powers. For instance, primary legislation might delineate the scope, objectives, and procedural parameters for delegated legislation, thereby limiting interpretive or implementation discretion by the executive.

b. Discretionary Delegated Rules: Conversely, many delegated legislative powers afford significant discretion to administrative bodies, enabling them to adapt regulations to specific circumstances or evolving contexts. Discretionary delegated rules offer flexibility in interpretation and application, allowing administrative bodies to address complex issues within their areas of expertise. This discretion often involves the exercise of judgment informed by policy considerations, technical expertise, or public interest concerns.

c. Balancing Delegated Rules: Certain delegated legislative powers necessitate administrative bodies to reconcile competing interests or policy objectives when formulating regulations. These rules require decision-makers to balance divergent considerations within a framework of legal principles or statutory goals. Decision makers must weigh various factors to achieve a reasonable equilibrium between competing interests. Comprehending discretion-based classification in delegated legislation is vital for evaluating the breadth of authority delegated to administrative bodies, assessing the legitimacy of regulatory decisions, and ensuring accountability in delegated powers’ exercise. It enables stakeholders to discern the latitude or constraints in delegated rules and engage effectively in the regulatory process by providing feedback on policy priorities and implementation strategies. Additionally, discretion-based classification serves to mitigate potential abuses of delegated authority, fostering transparency and coherence in regulatory decision-making.

3. PURPOSE-BASED CLASSIFICATION:

This classification considers the different purposes served by delegated legislation. Examples include Enabling Acts, Alteration Acts, Taxing Acts, Supplementary Acts, Classifying and Fixing Standard Acts, and Penalty for Violation Acts. Purpose-based classification for delegated legislation involves grouping regulations based on their underlying objectives or functions. Unlike discretion-based classification, which focuses on the extent of authority granted to administrative bodies, purpose-based classification examines the goals or purposes of the regulations. Here’s how purpose-based classification works for delegated legislation:

A. Regulatory Purposes: – Protective Regulations: These aim to ensure public health, safety, or welfare by establishing standards, restrictions, or risk mitigation measures. Examples include regulations for food safety, workplace safety, environmental protection, and consumer rights. – Economic Regulations: These seek to foster economic stability, fairness, or efficiency by regulating markets, industries, or economic activities. Examples include banking regulations, competition laws, trade policies, and consumer protection
measures. – Social Regulations: These address social issues or inequalities by promoting equality, inclusion, or social justice. Examples include regulations related to employment rights, anti-discrimination measures, housing policies, and education standards.

B. Administrative Purposes: – Procedural Regulations: These establish procedures, methods, or requirements for administrative actions or processes. Examples include regulations governing administrative hearings, rulemaking procedures, licensing processes, and administrative appeals. – Organizational Regulations: These govern the internal operations, structures, or functions of government agencies or departments. Examples include regulations concerning staffing, budgeting, procurement, and record-keeping. – Coordination Regulations: These facilitate coordination, cooperation, or collaboration among government agencies, levels of government, or stakeholders. Examples include regulations establishing interagency task forces, information-sharing protocols, or joint initiatives.

C. Policy Objectives: – Preventive Regulations: These aim to prevent harm, misconduct, or undesirable outcomes by imposing preventive measures or requirements. Examples include regulations requiring safety inspections, background checks, or risk assessments.
Remedial Regulations: These address existing problems, injustices, or deficiencies by remedying past harms or implementing corrective measures. Examples include regulations providing compensation for victims of fraud, discrimination, or environmental damage. – Developmental Regulations: These promote progress, innovation, or growth by fostering economic development, technological advancement, or social improvement. Examples include regulations incentivizing research and development, entrepreneurship, or infrastructure investment. Purpose-based classification helps stakeholders understand the intended objectives and impacts of regulations, enabling them to assess effectiveness, relevance, and coherence. It supports targeted interventions, policy evaluations, and regulatory reforms by identifying areas where regulations may be lacking, overlapping, or conflicting in their purposes. Additionally, purpose based classification enhances transparency and accountability by aligning regulations with broader policy goals and public interests.

4. AUTHORITY-BASED CLASSIFICATION (SUB-DELEGATION): This classification is based on the position of the authority making the rules. It includes sub delegated legislation, where the rule-making authority delegates its power to issue rules to itself or to some other subordinate authority. Authority-based classification, especially in the context of sub-delegation, involves organizing delegated legislation according to the extent to which administrative bodies are permitted to further delegate their legislative powers. Sub delegation occurs when an entity with the authority to create regulations under primary legislation delegates this authority to another entity.

Here’s a detailed breakdown:
a. Non-Delegable Authority: – Some primary legislation explicitly forbids sub-delegation, ensuring that the entity entrusted with regulatory authority cannot delegate it to others. This preserves accountability, ensuring that regulatory decisions are made by bodies directly accountable to the legislature or the public. It also maintains clarity in the regulatory process.

b. Limited Sub-Delegation: – Primary legislation may allow limited sub-delegation, permitting the initial administrative body to delegate certain administrative functions or tasks related to regulation within specified conditions or limits. This approach enhances efficiency while retaining oversight and control over the regulatory process.

c. Unrestricted Sub-Delegation: – In some instances, primary legislation grants unrestricted sub-delegation authority, enabling the initial administrative body to delegate its entire regulatory authority without constraints. This can enhance flexibility in regulatory decision making but raises concerns about accountability and coordination. Authority-based classification in sub-delegation clarifies the scope of delegated powers, the discretion granted to administrative bodies, and mechanisms for accountability. It helps stakeholders understand regulatory governance dynamics, identify potential challenges, and assess regulatory frameworks’ effectiveness. Additionally, it facilitates the design of regulatory structures that balance flexibility and accountability, ensuring that regulatory decisions serve the public interest while maintaining legitimacy and transparency.

ESSENTIAL CHARACTERISTICS OF DELEGATED LEGISLATION

Derived Authority: Delegated legislation derives its authority from an enabling Act of Parliament. The primary legislation grants powers to a specific authority or body to create laws within defined limits.

Supplemental Legislation: It supplements the provisions of primary legislation by providing detailed regulations, rules, or orders necessary for the implementation and administration of the law.

Flexibility: Delegated legislation allows for flexibility in adapting laws to changing circumstances without the need for frequent amendments to primary legislation. This flexibility is particularly useful in areas where technical or detailed provisions are required.

Expertise: Delegated legislation often allows for technical matters to be addressed by relevant experts or specialized bodies, ensuring that the regulations are formulated with appropriate expertise.

Speed and Efficiency: Delegated legislation can be enacted more quickly than primary legislation, making it an efficient tool for responding to urgent or rapidly changing situations.

Control and Oversight: While delegated legislation provides flexibility, it is subject to certain controls and oversight mechanisms. These may include parliamentary scrutiny, judicial review, or specific procedures outlined in the enabling Act to ensure that the delegated powers are not abused.

Limited Scope: Delegated legislation must operate within the confines of the powers granted by the enabling Act. It cannot go beyond what is authorized by the primary legislation.

Subordinate Status: Delegated legislation is subordinate to primary legislation. If there is a conflict between the two, primary legislation prevails.
Various Forms: Delegated legislation can take various forms, including statutory instruments, orders in council, regulations, by-laws, and administrative rules, depending on the nature of the authority and the subject matter.

Revocability and Amendment: Delegated legislation can typically be revoked or amended by the same authority that created it, subject to any procedural requirements or limitations specified in the enabling Act.

THE NEED FOR DELEGATED LEGISLATION

Delegated legislation is necessary for several reasons:
Detailed Implementation: Often, primary legislation provides broad principles or frameworks, leaving detailed implementation to delegated legislation. This allows for a more precise and practical application of laws to specific circumstances.

Expertise and Specialization: Delegated legislation enables relevant authorities or expert bodies to address technical, complex, or specialized matters within their respective domains. This ensures that regulations are formulated with the necessary expertise and understanding of the subject matter.

Flexibility and Adaptability: Delegated legislation provides flexibility to respond promptly to changing circumstances, emerging issues, or advancements in technology without the need for lengthy and cumbersome parliamentary procedures. This agility is essential in areas where laws need to keep pace with evolving realities.

Efficiency and Timeliness: Delegated legislation can be enacted more quickly than primary legislation, allowing for timely responses to urgent situations or emerging needs. This efficiency is particularly crucial in areas such as public health, emergency management, and economic regulation.

Administrative Detailing: Delegated legislation fills in administrative details necessary for the effective functioning of government agencies and departments. It specifies procedures, requirements, and standards that facilitate the smooth operation of public services and regulatory processes.

Consistency and Uniformity: Delegated legislation helps ensure consistency and uniformity in the application of laws across different regions or sectors. It allows for the creation of standardized regulations that promote fairness and equity in governance and enforcement.

Parliamentary Scrutiny and Control: Although delegated legislation grants powers to executive bodies, it remains subject to parliamentary scrutiny and control. This ensures accountability and oversight, preventing the misuse or abuse of delegated powers.

Special Circumstances: Delegated legislation is useful in addressing special circumstances or emergencies where prompt action is necessary. It provides a legal mechanism for temporary measures or adjustments to existing laws without the need for extensive legislative processes.

Cost-effectiveness: Delegated legislation can be a cost-effective way to regulate complex or technical matters, as it allows for detailed regulations to be developed by specialized bodies or agencies without the need for extensive parliamentary time and resources.

Democratic Governance: Delegated legislation contributes to democratic governance by facilitating public participation and consultation in the rule-making process. While the primary legislation is enacted by elected representatives, delegated legislation often involves input from stakeholders and affected parties, enhancing transparency and accountability.

ADVANTAGES OF DELEGATED LEGISLATION:
1. Delegated legislation is more flexible than an Act of Parliament. It is far simpler to amend a piece of delegated legislation than to amend an Act of Parliament.

2. Parliamentary time is saved on relatively trivial matters. Local knowledge is usually desirable in deciding what local by- laws should be passed. This task, therefore, is given to the local authorities. Delegated legislation is far quicker to introduce than an Act of Parliament.

3. This can be an advantage in instances when emergencies or unforeseen problems require laws to be changed. The detail of the delegated legislation can be dealt with by the appropriate minister, leaving Parliament as a whole more time to focus on the general principles of the enabling Act.

4. Delegated legislation by its very nature concerns specialist technical and/or local knowledge. So it is an advantage for such specialist provisions to be dealt with by those who have this knowledge rather than by Members of Parliament who generally would not have the required specialist or local knowledge.

DISADVANTAGES OF DELEGATED LEGISLATION: 

1.Accountability issue is the problem that the authority vested in Parliament to make law is delegated away from Parliament, possibly through a number of „layers‟, for example, to a government minister and to a department and then possibly again to a group of experts.

2. The large volume of delegated legislation produces about 3000 statutory instruments each year which means that it is very difficult for Members of Parliament, let alone the general public, to keep up to date with the present law. This is exacerbated by the fact that delegated legislation is made in private.

3. The main criticism of delegated legislation is that it takes law making away from the democratically elected House of Commons. Instead, power to make law is given to unelected civil servants and experts working under the supervision of a government minister.

4. The accountability issue is the problem of adequate scrutiny. The detailed, technical and specific nature of much-delegated legislation means that, on the whole, Members of Parliament do not have the expertise to consider proposed legislation effectively.

CRITICISM ON DELEGATED LEGISLATION

Following are the criticism of delegated legislation:
1. Delegated legislation results in overlapping of functioning as the delegated authorities get work to amend the legislation that is the function of the legislators.
2. It has been a matter of question that if the Legislature control has come down after the arrival of the delegated legislation.
3. Unelected people cannot make much delegated legislation as it would be against the spirit of democracy.
4. After getting too much power from the Legislature, the Executive has encroached upon the domain of legislature by making rules and regulations.
5. The enactment subject that was appointed to less Parliamentary scrutiny than essential enactment. Parliament, along these lines, has an absence of authority over appointed enactment, and this can prompt irregularities in laws. Appointed enactment, in this way, can possibly be utilized in manners which Parliament had not foreseen when it was given the power through the Act of Parliament.
6. Delegated legislation makes laws without much discussion. So, it may or may not be better for the public.
7. It can possibly be misused for political gain. The executive makes law according to what the political parties. Hence, it results in the misuse of the legislation made by the Executive by the ruling party.
8. Executives become too powerful as it already has the power of executing any laws and legislation and now the Legislature is delegating its legislative power to the Executive. So, both the power is in the hands of the executives now he can use this power in whatever way he wants to use it. It is against the theory of the power of separation which has been given by the famous political thinker Montesquieu.

CONCLUSION

Delegated or subordinate legislation means rules of law made under the skilled person of Act of Parliament. In spite of the fact that law-making is within the capacity of the law making body, it might, by a resolution, delegate its capacity to different bodies or people. The resolution which delegates such power is known as the Enabling Act. By Enabling Act the council sets out the wide rules and nitty-gritty principles are instituted by the delegated authority.If in India the control of Parliament over the delegated legislation has to be made a living continuity, then it is important that the job of the advisory groups of the Parliament must be fortified and a different law like the Statutory Instruments Act, accommodating uniform standards of laying and production, must be passed. The board of trustees might be enhanced by a specific authority body to make the watchfulness of assigned enactment progressively successful. Other than the different measures mentioned above, it should be taken to reinforce the control of Parliament over designated enactment. The tenets and standards created by the Legal Executive should be connected by the necessities of the advanced age. In spite of the fact that there are no express arrangements in the Constitution of India to allow the appointment of authoritative power, the legal pattern saw in regard of assigned enactment is as per the aim of establishing fathers our Constitution whose principal concern was the flexibility of the Constitution with changing needs of the of the time. If you want to make certain that the power of delegated law in the arms of the government is not misuse, it is vital to adopt powerful modes of control as applicable in the USA which India has now not integrated yet.

REFERENCES
Bharadvaja, Brahma. Delegated Legislation in India. Meerut: Meenakshi Prakashan, 1975. [2]. Carr, Cecil T. Delegated Legislation. Cambridge University Press, 2016.
[3].Chen, Chih-Mai. Parliamentary Opinion of Delegated Legislation. 1933, doi:10.7312/chen92244.
[4]. Clements, Richard. “11. Administrative Law: Ombudsmen, Tribunals, and Delegated Legislation.” Law Trove, 2018, doi:10.1093/he/9780198819912.003.0011.
[5]. Donnelly, Sarah, et al. “How Are People with Dementia Involved in Care-Planning and Decision-Making? An Irish Social Work Perspective.” Dementia, Jan. 2018, p. 1471301218763180.
[6]. Elliott, Mark, and Jason Varuhas. “16. Delegated Legislation.” Law Trove, 2017, doi:10.1093/he/9780198719465.003.0016.
[7]. Fraser, Alan G., et al. “The Need for Transparency of Clinical Evidence for Medical Devices in Europe.” The Lancet, vol. 392, no. 10146, Aug. 2018, pp. 521–30.
[8]. Goetz, Katja, et al. “At the Dawn of Delegation? Experiences and Attitudes of General Practitioners in Germany – a Questionnaire Survey.” BMC Family Practice, vol. 18, no. 1, Dec. 2017, p. 102.
[9]. Great Britain: Parliament: House of Lords: Select Committee on the Constitution. HLP 116 – Delegated Legislation and Parliament: A Response to the Strathclyde Review. The Stationery Office, 2016.
[10]. Hewitt, Desmond J. The Control of Delegated Legislation: Being a Study of the Doctrine of Ultra Vires in Relation to the Legislative Powers of the Executive Government, with Special Reference to Great Britain, Australia, New Zealand and Canada. Sydney : Butterworth, 1953.
[11]. “III. Parliamentary Criticisms of Delegated Legislation.” Parliamentary Opinion of Delegated Legislation, 1933, pp. 68–89, doi:10.7312/chen92244-003.
[12]. Martinek, Madeleine. Experimental Legislation in China between Efficiency and Legality: The Delegated Legislative Power of the Shenzhen Special Economic Zone. Springer, 2019.
[13]. Merks, Piotr, et al. “The European Falsified Medicines Directive in Poland: Background, Implementation and Potential Recommendations for Pharmacists.” European Journal of Hospital Pharmacy. Science and Practice, vol. 25, no. 1, Jan. 2018, pp. 10–15.