Source:
African Union
Addis Ababa, June 1999
PREAMBLE
Whereas, modern biotechnology might have much promise for the improvement of human well-being, its potential adverse effects on the environment, biological diversity and human health are causing a growing public concern;
Whereas, it is the responsibility of the Government to ensure the safety of the people and the environment with respect to the risks arising from genetically modified organisms (GMOs) and products of genetically modified organisms resulting from modern biotechnology;
Whereas, with the potential risks posed by genetic modification it is consistent with the precautionary principle to regulate any undertaking for the import, contained use, release or placing on the market of genetically modified organisms and products of genetically modified organisms;
Whereas it is important to enhance the capacity which is necessary to cope with the nature and scale of known and potential risks associated with genetically modified organisms and products of genetically modified organisms;
Now, therefore, it is hereby legislated as follows
ARTICLE 1
DEFINITIONS
For the purposes of this law:
"Advance informed agreement" means consent obtained based upon full disclosure of all relevant information and the taking of full responsibility by the supplier of the information for its accuracy and completeness before any activity is undertaken.
"Applicant" means any natural or legal person who submits an application in writing to the Competent Authority seeking approval to import, make contained use of, release or place on the market genetically modified organisms or products of genetically modified organisms, or where the context so requires, any person to whom the approval has already been granted.
"Cell technology" means techniques for the production of living cells with new combinations of genetic material by the fusion of two or more cells
"Contained use" means any operation in which genetically modified organisms are grown, stored, destroyed or used in some other way in a closed system not exceeding xcm3 in volume in which physical barriers are employed either alone or together with chemical and/or biological barriers, to effectively prevent their contact with, and their impact on, humans and the external environment.
"Deliberate release" or "release" means any intentional introduction into the environment or a genetically modified organism or a product of a genetically modified organisms, this includes releaser for: commercial purposes, aid food, remediation, research purposes in field experiments, use of genetically modified organisms in green houses, aqua-culture facilities, animal accommodation unless the facility is approved for contained use, as a part of an approved laboratory or other installations, disposal of waste containing genetically modified organisms, import, export or transport of genetically modified organisms or products of genetically modified organisms.
"Export" from a given country means the intentional transboundary movement from that country to another country.
"Exporter" means any legal or natural person who arranges for a genetically modified organism or a product of a genetically modified organism to be exported.
"Gene technology" means any technique that involves the isolation, characterization, modification or introduction of DNA into living cells, viruses or plasmids.
"Genetically modified organism (GMO)" means any biological entity, capable of replication or of transferring genetic material and includes plants, animals, micro-organisms (viruses, bacteria, plasmids), cell cultures and other vector systems in which the genetic material has been altered through modern biotechnology. This includes genetic modification which occurs through the following techniques:
- recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside and organism into a virus, bacterium, plasmid or other vector, and their incorporation into a host organisms in which they do not naturally occur but in which they are capable of continued propagation;
- Techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation; and
- Cell fusion (including protoplast fusion) or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells.
"Import" into a given country means the intentional transboundary movement into that country form another country.
"Importer" means any legal or natural person who arranges for a genetically modified organism or a product of a genetically modified organism to be imported
"Notification" means providing information to and where appropriate, the lodging of samples with, the Competent Authority, at the same time as taking responsibility for the accuracy and completeness of the information.
"Person" includes both natural and legal entities.
"Placing on the market" means supplying of making available to third parties a genetically modified organism or a product of a genetically modified organism, whether there has been monetary exchange or not, and includes the giving as aid food.
"Product of a genetically modified organism" means any material derived by processing, or howsoever otherwise, from any genetically modified organism or from a product of a genetically modified organism.
"Risk Assessment" means the evaluation of the direct and indirect, short, medium and long term risk to the environment, biological diversity or human health, including socio-economic conditions or to ethical values arising from the contained use, release or placing on the market of a genetically modified organism or of a product of a genetically modified organism.
"Socio-economic impact" means the direct or indirect effect of a genetically modified organism, or a product of a genetically modified organism on the economy or on social or cultural conditions or on the livelihood or indigenous knowledge systems or technologies of a community or communities, including on the economy of the country.
"Use" excludes the acquisition from local markers or from nationally authorized sources, including aid food, by purchase or otherwise, by a member of the general public and utilisation r dealing thereafter unless specific conditions have been attached regarding the utilisation.
ARTICLE 2
SCOPE
This law shall apply to the import, export, transit, contained use, release or placing on the market of any genetically modified organism whether intended for release into the environment, for use as a pharmaceutical, for food, feed or processing or a product of a genetically modified organism.
ARTICLE 3
INSTITUTIONAL ARRANGEMENTS
1. National Focal Point
The government shall designate or establish a National Focal Point to be responsible on its own behalf for liaison with the Secretariat of the Protocol and Clearing-House and facilitate the exchange of information among the relevant bodies and authorities.
2. Competent Authority
The Government shall designate or establish a Competent authority to follow up, supervise and control the implementation of this law. The powers and duties of the Competent Authority shall include the following:
- To prescribe criteria, standards, guidelines and regulations as may be necessary for the fulfilment of the objective of this law;
- To take into account the policy recommendations and other guidelines of the National Biosafety Committee in making decisions on the import, transit, contained use, release or placing on the market of a genetically modified organism;
- To cause the establishment of Institutional Biosafety Committees at relevant institutions or nominate independent panels or any other body of experts, as appropriate, as technical and scientific advisors on issues of biosafety;
- To keep genetically modified organisms globally under constant review and when any one of them is suspected of posing a serious risk to human health or to the environment, to ban its transiting through the country’s territories and notify the Clearing-House, the customs and trade officials accordingly;
- To inform the Secretariat of the Cartagena Protocol, if appropriate, that it has no access to the Clearing-House.
- To maintain and make available to the public on request, a data base on genetically modified organisms and products of genetically modified organisms intended for direct use as food or feed, or for processing.
- To declare through Biosafety Clearing-House that:
(i) A genetically modified organism or a product of a genetically modified organisms intended as food or feed or for processing may be imported only after it has been subjected to a full risk assessment according to this law, and
(ii) It is an application to import that will trigger the risk assessment and that is shall not automatically happen every time a new genetically modified organism is posted in the Clearing-House;
- To review, make or have made risk assessments of genetically modified organisms or products of genetically modified organisms. When the genetically modified organism or the product of a genetically modified organism is to be imported, the cost will be borne by the exporter;
- To take legal measures nationally or internationally to protect human health and the environment from risks that may be posed by genetically modified organisms or of their products, inter alia, though enforcing this law and the Cartagena Protocol on Biosafety;
- To designate inspectors and undertake inspection as well as other control measures to ensure compliance with this law; and
- Any other functions as may be specified by the government.
3. National Biosafety Committee
- A National Biosafety Committee comprising representatives of governmental and non-governmental organizations, and the private sector that are relevant to the issues of biotechnology and biosafety shall be established by the government to provide, as appropriate, policy recommendations and guidelines to the Competent Authority.
- The National Biosafety Committee shall further develop based on its general responsibility specified in 2(a) of this Article, its terms of reference and may draw up its won rules of procedure.
- A member of a National Biosafety committee who finds a conflict of interest in the case at hand shall so declare it and withdraw from the Committee in so far as that case of conflict of interest is concerned.
4. Instional Biosafety Committee
Institutions that are involved in the import, export, handling , contained use, release or placing on the market of genetically modified organisms or products of genetically modified organisms shall establish Institutional Biosafety Committees to institute and control safety mechanisms and approval procedures at the institution level.
ARTICLE 4
APPLICATION
1. No person shall import, transit, carry out the contained use of or release of, or place on the market a genetically modified organism or a product of a genetically modified organism without an advance informed agreement or the explicit written approval of the Competent Authority, whichever is appropriate.
2. Any person who wishes to carry out any import, or deliberate release, or contained use of, or place on the market, a genetically modified organism or a product of a genetically modified organism shall submit an application in writing to the Competent Authority.
The application shall include:
- The information specified in annex 1 and such other information as may be prescribed by the Competent Authority;
- Assessment report on risks that may be posed by the genetically modified organism or product of a genetically modified organism upon the environment, biological diversity or human health, including the consequences of unintentional release;
- Information from previous or current release of the genetically modified organism or product of a genetically modified organism by any other country;
- If the request for approval is for the purposes of research and development the recommendations of the institutional Biosafety Committee;
- A clear and sequential description of the steps to be taken in the implementation of the project, and the monitoring and evaluation that will be made at the end of each step, and the method of disposing any waste;
- A place where and the purpose for which the genetically modified organism or the product of a genetically modified organism is planned to be developed, used, kept, released or marketed, including detailed instructions for use and a proposed labelling and packaging scheme in accordance with annex II, part C of this law; and
- The applicant shall submit a declaration confirming that the information provided is correct including, where appropriate, an undertaking from the originator of such information affirming its accuracy and completeness.
4. Any person who wishes to import a genetically modified organism or a product of a genetically modified organism for direct use as food or feed, or for processing, shall submit an application in writing with a reference to the information on the item found in the Clearing-House, to the Competent Authority.
ARTICLE 5
PUBLIC PARTICIPATION
1. The Competent Authority shall, upon receipt of the information refereed to under Article 4.3 and Article 4.4, make available the said information to the public and relevant government authorities.
2. The public may make comments within such period and in such a manner as may be specified by the Competent Authority, which should, however, be long enough for meaningful public reaction.
3. In cases where the Competent Authority arranges for a public consultation with regard to any proposed import, contained use, release or pacing on the market of a genetically modified organism or a product of a genetically modified organism, this fact shall be announced in a media with national coverage and a period of not less than .. days shall pass before the decision is made.
4. The Competent Authority shall, in making or reviewing its decision take into account the views and concerns of the public expressed in accordance with paragraphs (2) and (3) of this Article.
5. The Competent Authority shall make available to the public:
- Information on any genetically modified organism or a product of a genetically modified organism, which has been granted or denied approval for import, contained use, release or placing on the market; and
- In particular, any risk assessment report with respect to the genetically modified organism or the product of a genetically modified organism.
ARTICLE 6
DECISION MAKING PROCEDURE
1. The Competent Authority shall ensure that the first import of a genetically modified organism or the product of a genetically modified organism into the country is made only after it has given its approval in writing.
2. The Competent Authority shall evaluate the information presented by the applicant or in the Clearing-House, as the case may be, and may decide that the applicant:
- Needs to provide more information to enable decision-making;
- May proceed with her/his/its request; or
- May proceed with her/his/its request but only under such conditions as the Competent Authority may specify; or
- Shall not be allowed to proceed with her/his/its request.
3. The Competent Authority shall notify the applicant in writing and the public of its decisions copied to the Clearing-House.
4. The Competent Authority may, prior to its taking a decision, request for further information as it may deem necessary and any applicant who fails to supply the required further information shall be deemed to have withdrawn her/his/its application.
5. Any approval shall specify the step-y-step sequences of implementation that risk assessment shall be conducted at each step, provided that the Competent Authority, may in appropriate cases, not require this procedure if it is satisfied that there would be no risk/significant risk to the environment, biological diversity or human health.
6. Any approval for import, contained use, release or placing in the market of a genetically modified organism shall require the applicant to carry out monitoring and evaluation of risks on a continuing basis for a period commensurate with the life cycle of the species, as determined by the Competent Authority.
7. No approval shall be given unless there is a firm and sufficient evidence that the genetically modified organism or the product of a genetically modified organism poses no risks/significant risks to the environment, biological diversity or human health.
8. In any event, where there is reason to suspect threats of serious damage, lack of scientific evidence shall not be used as a basis for not taking preventive measures.
9. No approval shall be given unless it is considered and duly determined by the Competent Authority that the import, contained use, release or placing on the market of the genetically modified organism or the product of a genetically modified organism will:
- Benefit the country without causing any significant risk to the environment, biological diversity or human health;
- Contribute to sustainable development;
- Not have adverse socio-economic impacts; and
- Accord with the ethical values and concerns of communities and does not undermine community knowledge and technologies.
10. The Competent Authority shall, as a condition for approval, require the applicant to furnish evidence of insurance cover or some other arrangements sufficient to meet its obligations under this law.
ARTICLE 7
REVIEW OF DECISION
1. Any approval given may be revoked, or subjected to conditions in addition to those originally imposed, if there has been a change in circumstances, or if, in the opinion of the Competent Authority, new information obtained or a review of existing information about the genetically modified organism or the product of a genetically modified organism indicates risks to the environment, biological diversity or human health.
2. Where information becomes available after approval on the possible risks to the environment, biological diversity or human health, the applicant shall immediately notify the Competent Authority.
ARTICLE 8
RISK ASSESSMENT
1. The applicant shall carry out or cause to be carried out an assessment of any risks associated with a genetically modified organism or a product of a genetically modified organism in respect of which she/he/it is applying.
2. No decision on any application to import, make contained use of, release or place on the market a genetically modified organism or a product of a genetically modified organism may be made by the Competent Authority without the assessment of risks to the environment, biological diversity and human health, including the socio-economic conditions and cultural norms.
3. The risk assessment of a genetically modified organisms or a product of a genetically modified organism shall be carried out by the applicant or the Competent Authority as appropriate, on a case by case basis and shall be done in accordance with Annex III.
4. The Competent Authority shall evaluate or cause the evaluation of the risk assessment report and consider the result of such an evaluation in making a decision on any application to import, make contained use of, release or place on the market a genetically modified organism or a product of a genetically modified organism.
5. In case where the evaluation of the assessment shows that risks cannot be avoided, the Competent Authority shall refuse approval for the import, contained use of, release or placing on the market the genetically modified organism or the product of a genetically modified organism.
6. In the case of a refusal to approve under paragraph 5 above, any patent or an application for a patent on the genetically modified organism or product of a genetically modified organism shall be revoked or rejected as the case may be.
7. The Competent Authority may require the applicant to bear all the costs for evaluating the risk assessment report or carrying out the risk assessment, as the case may be.
8. No person shall be involved in the evaluation of a risk assessment in respect of a subject matter in which s/he has any direct or indirect interest of any kind, or if, for any reason, there is, or there is likely to be, a conflict of interest as a result of her/his participation in the evaluation process. A person with a conflict of interest shall declare the fact and withdraw from the evaluation process.
9. If an independent risk assessment cannot be undertaken, or if there is no possibility of verifying the independence of the risk assessment, the Competent Authority may reject the application.
ARTICLE 9
RISK MANAGEMENT
1. The Competent Authority shall develop, maintain and use as the need arises, an accident containment strategy to human health, biological diversity and, in general, the environment from accidents in genetic engineering, the use of genetically modified organisms, and their products.
2. The Competent Authority shall impose such measures, as may be necessary to implement Annex IV and to avoid adverse effects on the environment, biological diversity and human health, including on socio-economic conditions arising from a genetically modified organism or a product of a genetically modified organism.
3. Without limiting the generality of paragraphs 9(1) and 9(2), the Competent Authority may:
- Require any genetically modified organisms to undergo a period of observation commensurate with its life-cycle or generation time, at the cost of the applicant, before and after it is put to its intended use;
- Prohibit the import, contained use, release or placing on the market of any genetically modified organism or the product of a genetically modified organism, if it contains characteristics or specific traits which pose unacceptable risks to the environment, biological diversity, human health, socio-economic conditions or cultural norms;
- Order the cessation of any activity, which is being undertaken in violation of any of the provisions of this law or any decisions made under it;
- Order the cessation of any activity involving a genetically modified organism or a product of a genetically modified organism that is known to cause risks to the environment, biological diversity or human health.
- Require the person responsible for any activity under this law to take such measures as may be necessary to prevent or limit any harm to the environment, biological diversity, human health, or socio-economic conditions, or to restore the environment to its previous state as far as is feasible.
- Undertake measures, as necessary, at the cost of the person responsible, in the event that the person responsible fails to undertake safety measures prescribed by the Competent Authority;
- Take measures, as necessary, in the case of imminent and serious danger to the environment, biological diversity, human health, socio-economic conditions, or ordre public caused by a genetically modified organism or a product of a genetically modified organism, at the cost of the person responsible for causing such danger; and
- Require the applicant to submit reports periodically in respect of the monitoring and evaluation of risks carried out after the approval of the import, contained use, release or placing on the market of a genetically modified organism or a product of a genetically modified organism.
ARTICLE 10
UNINTENTIONAL RELEASE AND EMERGENCY MEASURES
1. In order to manage the unintentional release and emergency, the Competent Authority shall, as necessary, ensure, that:
- An emergency plan is drawn up for the protection of human health, biological diversity and, in general, the environment outside the area of release or contained use of an accident and the appropriate emergency services are aware of the hazards and are informed in writing; and
- Information on safety measures and procedures to adopt in the case of an accident is made available by the applicant to persons likely to be affected by the accident. The information shall be updated and made available periodically. It shall also be made available to the general public.
2. The applicant shall inform the Competent authority immediately of any accident and provide the following information:
- The circumstances of the accident;
- The identity and quantity of the genetically modified organism or products of genetically modified organism released unintentionally;
- Any measure necessary to assess the effects of the accident on the environment, biological diversity or human health; and
- The emergency measures taken or to be taken.
3. Upon receipt of the information under paragraph 10(2), the Competent authority shall;
- Ensure that all measures possible have been taken to neutralize risks to human health and biological diversity; and
- Inform relevant government and non governmental organizations in countries likely to be affected, and the Biosafety Clearing-House.
ARTICLE 11
IDENTIFICATION AND LABELLING
1. Any genetically modified organism or product of a genetically modified organism shall be clearly identified and labelled as such, and the identification shall specify the relevant traits and characteristics given in sufficient detail for purposes of traceability.
2. Any genetically modified organism or any product of a genetically modified organism shall be clearly labelled and packaged using the words given in annex II part C, and shall comply with such further requirements, if any, imposed by the Competent Authority, to indicate that it is, or has been derived from, a genetically modified organism, and where applicable, whether it may cause allergies or pose other risks.
ARTICLE 12
CONFIDENTIAL BUSINESS INFORMATION
1. The Competent Authority shall protect information which it determines as being confidential following a claim for confidentiality made in writing has been made by the applicant.
2. In no case may the following information supplied by the applicant be kept confidential:
- Description of the genetically modified organism or the products of a genetically modified organism, names and addresses of the applicant, purpose and location of the import, contained use, release or placing on the market or the genetically modified organism or the product of a genetically modified organism;
- Methods and plans for monitoring the genetically modified organism or the product of a genetically modified organism and for emergency response; and
- The evaluation of possible effects, in particular any pathogenic and/or ecologically disruptive effects
3. The Competent Authority may make available the information referred to in Article 4(3) and 4(4) to the public pursuant to Article 5(1), notwithstanding that it may be commercially confidential if it decides that it is in the public interest to do so.
4. If the applicant withdraws the application before approval, the Competent authority must respect the confidentiality of the information except for the information referred to in sub-paragraphs (2) and (3) of this Article.
5. Any person carrying out any activity covered by this law shall supply information necessary for the Competent Authority to carry out its supervisory or monitoring or enforcement tasks or to deal with any emergency measures in relation to the activity and there shall be no claim of confidentiality in relation to such information.
ARTICLE 13
EXPORT
1. Any person who intends to export a genetically modified organism or a product of a genetically modified organism shall provide to the Competent Authority a written advance informed agreement of the Competent authority of the importing country.
2. The presentation of the advance informed agreement by an exporter shall in no way absolve the exporter from complying with any other laws governing foreign trade.
3. The submission of the advance informed agreement shall not preclude the country of the exporter from taking into account other considerations in deciding whether or not to approve the export.
4. There shall be no authorization for the re-export of a genetically modified organism or product of a genetically modified organism that has been banned by the laws of the exporting country.
ARTICLE 14
LIABILITY AND REDRESS
1. A person who imports, makes contained use of, releases or places on the market a genetically modified organism or a product of a genetically modified organism shall be strictly liable for any harm caused by such a genetically modified organism. The harm shall be fully compensated.
2. Liability shall attach to the person responsible for the activity which results in the damage, injury or loss as well as to the provider, supplier or developer of the genetically modified organism or of the product of a genetically modified organism.
3. If there is more than one person responsible for the damage, injury or loss, then the liability shall be joint and several.
4. In the case of harm to the environment or biological diversity, compensation shall include the costs of reinstatement, rehabilitation or clean-up measures which actually are being incurred and, where applicable, the cists of preventive measures.
5. Liability shall also extend to harm or damage caused directly or indirectly by the genetically modified organism or product of the genetically modified organism to the economy or social or cultural conditions, the livelihood or indigenous knowledge systems or technologies of a community or communities, or incidents of public disorder triggered by the genetically modified organism or the product of a genetically modified organism. Such harm includes inter alia the following: disruption or damage to production systems, agricultural systems, reduction in yields, soil contamination, damage to the biological diversity, damage to the economy of an area or community, or any other consequential disorder.
6. The right to bring any action in respect of the harm caused by a genetically modified organism or a product of a genetically modified organism shall lapse only after a reasonable period from the date on which the affected person or the community could reasonably be expected to have learned of the harm, taking due account of:
- The time the harm may take to manifest itself; and
- The time that it may reasonably take to correlate the harm with the genetically modified organism or the product of the genetically modified organism having regard to the situation or circumstance of the person or community affected.
7. Any person, group of persons, or any private or state organisation may be entitled to bring a claim and seek redress in respect of the breach or threatened breach of any provision relating to damage to the environment, to biological diversity, to human health or to socio economic conditions:
- In that person’s or group of person’s interest;
- In the interest of, or on behalf of, a person who is, for practical reasons, unable to institute such proceedings;
- In the interest of, or on behalf of, a group or class of person whose interests are affected;
In the public interest; and
- In the interest of protecting the environment or biological diversity.
8. No costs shall be awarded against any of the above persons who fail in any action as aforesaid if the action was instituted reasonably out of concern for the public interest of in the interest of protecting human health, biological diversity and, in general, the environment or biological diversity.
9. If human health is adversely affected by a genetically modified organism or by a product of a genetically modified organism, legal action should be taken against the responsibly party, and the resulting decision will determine, as the case may be:
- The amount of medical expenses;
- Compensation for any disability suffered; and
- Compensation for loss of life
ARTICLE 15
OFFENCES AND PENALTIES
Any natural or legal person who:
- Imports, releases, places on the market or makes contained use of any genetically modified organism or products of a genetically modified organism without the written approval of the Competent Authority;
- Violates any conditions attached to the grant of approval under this law;
- Fails to furnish any information as required by the provisions of this law;
- Withholds information that has become available to her/him/it after the approval of her/his/its application, and that could change the evaluation of the risk posed by her/his/its project;
- Provides false, misleading or deceptive information under Article 4.3 in order to secure an approval;
- Does not label, package or identify any genetically modified organism or a product of a genetically modified organism in accordance with this law or with any conditions imposed under this law;
- Labels, packages or identifies any genetically modified organism or a product of a genetically modified organism in a manner that is false, misleading or deceptive or in contravention of ay regulation made under this law;
- Exports a genetically modified organism or a product of a genetically modified organism without the advance informed agreement of the importing country;
- Participates in proceedings related to decision taking in respect of a subject matter covered by this law in which she/he/it has any direct or indirect interest of any kind;
- Violates any other provision of this law or any condition or requirement imposed under this law;
- Fails to declare any conflict of interest arising in a National or Institutional Biosafety committee of which s/he is a member, or in the evaluation of a risk assessment in which s/he is involved and fails to withdraw from its activities in relation to that case.
- Uses for hostile purposes;
Commits an offence and is liable on conviction to imprisonment for a term not exceeding … years or to a fine or to both.
2. Any person shall upon conviction of an offence under Article 15.1 (a), (b) or (d), be prohibited from engaging in any activity in relation to genetically modified organisms or products of genetically modified organisms;
Such order of prohibition shall extend to any corporation, body or legal entity that may be used to avoid the effect of the said order.
3. Any person who repeatedly commits any other offence under this law may be prohibited from engaging in any activity in relation to genetically modified organism or products of genetically modified organisms.
4. Where the offence is committed by a corporation, and where the court feels that a custodial sentence ought to be imposed, the executive officer in charge at the time the offence is committed shall be liable to imprisonment.
ARTICLE 16
APPEAL
1. Any person aggrieved by any decision of the Competent Authority may, at any time within the period of … month(s) beginning from the date of receipt of the decision, appeal to such ajudicatory and/or administrative authority as may be set up by law.
2. In this section, ‘decision’ includes any act, omission, refusal, direction, imposition of condition(s) or order.
ARTICLE 17
TRANSITIONAL PROVISIONS
1. Regarding any import, contained use, release, or placing on the market of a genetically modified organism or a product of a genetically modified organism that has already bee carried out on the date when this law enters into force, an application for approval shall be made in accordance with Article 4 of this law.
2. The application shall be submitted to the Competent Authority within a time limit to be determined by the Competent Authority.
3. If the application has been made within the prescribed time limit, the activity in respect of which the application is made may continue until a decision is made by the Competent Authority under Article 6 of this law.
4. Any application pending at the date of the entry into force of this law shall be subject to the provisions of this law.
ARTICLE 18
ANNEXES
The annexes and any regulations made under or pursuant to this law shall be an integral part of this law
ARTICLE 19
ENTRY INTO FORCE
This law shall enter into force on the date of its publication in the official gazette.
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