A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, colour, taste, and packaging.
Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients.
The FDA's Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures that people have access to safe, affordable generic drugs by following a rigorous review process that includes:
Information about the generic drug review process, FDA standards and pricing, and answers to frequently asked questions
Electronic submission forms, requirements, guidance, reports, and other resources to help facilitate generic drug applications and approvals
First-time generic drug approvals, generic drug application review metrics, and Generic Drugs Program reports
FDA generic drug regulatory science initiatives, research priorities and reports, public workshops, and opportunities for collaboration
Infographics, brochures, handouts, posters, presentations, PSAs, and articles about generic drugs for educators, health care professionals, and consumers#
Generic drugs must meet high standards to receive FDA approval
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:
By Garibli A.
TAG: generic drugs, chemical substance, API, packaging, FDA,
These Terms & Conditions (hereinafter may also be referred to as the T&Cs””) of Makromed__ (hereinafter referred to as the “Makromed”), represent legal basis for relations between you and Makromed Co, which operates a third-party cross-border trade System for pharmaceuticals and medical devices independently developed by Makromed___ (hereinafter referred to as “the System”). Your use of the System (including but not limited to connecting to, accessing or browsing the System, or using various services or functions provided by the System) shall constitute your acceptance of these T&Cs. In view of this, you are advised to carefully read the contents of thereof.
1. The contents of the T&Cs shall include the text of the T&Cs as well as various regulations already published or will be possibly published in the future through the System. All regulations shall constitute an integral part of the T&Cs and have the same legal effect as the text of the T&Cs.
2. When you access the System and use any service in any manner, you shall be deemed as having fully read through, understood and accepted the terms and conditions of the T&Cs.
3. Individual terms of the T&Cs may be adjusted as appropriate depending on the demand of business, in which case a public announcement will be published on the website without any further notice sent to you separately. Once any term is amended, the amendment shall be issued immediately and shall come into effect at once. If you continue to use the services provided by the System, you shall be deemed as having fully read through, understood and accepted the amended term of the T&Cs. If you refuse to accept the amended term of the T&Cs, you have the right to stop using the services of the System. In case of any dispute occurred between you and the System, the latest version of the terms and conditions of the T&Cs shall prevail.
1. All users of the System shall be deemed to be natural persons, corporations and other organizations with full capacity for civil right and capacity for civil conduct corresponding to the civil conducts being engaged. If you do not have such capacity, you shall not use the System. Otherwise all consequences thereby caused shall be undertaken by you and your custodian.
2. The System has the right to cancel your account and no longer provide any service to those Users, whose memberships have been cancelled temporarily or permanently. Moreover the System reserves the right to investigate the legal liability of you and your custodian.
1. During registration, you may select a login name and a password at your discretion. You may use your mailbox, mobile phone number for registration or any other manner permitted by the System as the login method to access the System.
2. If you registerthe membership of the Systemor create a member account on behalf of third parties, you shall be deemed to be representing and warranting that you have the right and authority to make the aforesaid third partiesbound by the terms and conditions of the T&Cs.
3. While applying for registration of the membership of the System, you shall provide true, accurate, timely, complete registration information, including, but not limited to your name, nationality, contact number and e-mail address, and you shall promptly update and maintain your personal and business information to ensure such information is true, accurate, timely and complete.
1. While using the System, you are obligated to abide by relevant State laws, regulations and rules, and follow relevant agreements, regulations, rules and procedures of the System. The System shall not be used to engage in any illegal activity.
2. You shall assume all responsibilities independently for the truth, accurateness, timeliness, completeness and legality of any and all information published by you in the System, including but not limited to your personal data and business information. In case it is discovered that you provide wrong, untrue, outdated, incomplete or misleading information, or you provide any information which the System has good reason and basis to suspect to be wrong, untrue, outdated, incomplete or misleading, the System shall be entitled to suspend, cancel or permanently freeze your account and refuse to provide you with any service.
3. You shall keep your login name and password properly, and be responsible for all activities conducted by you through your account. By way of using the System you agree and acknowledge that: 1) in case of any unauthorized use of your login name and password or any other condition in violation of any provision of the T&Cs, you will notify the System immediately; 2) you will ensure to exit the System following the accurate procedure when each on-line period is over. The System shall assume no legal liability for any loss suffered by you due to your failure to observe the T&Cs.
4. The System shall have the right to send and furnish various kinds of business information with relation to the services provided by the System to you via the contact information provided by you (including but not limited to e-mail address and contact number etc.). If you refuse to receive above-mentioned business information, you have to notify us in a writing.
5. It is not allowed to publish any information which 1) infringes a third party’s property right, copyright, patent, trademark, trade secret, intellectual property, right of privacy, right of reputation or authorship; 2) contains any defamatory, intimidating, harassing, obscene, pornographic or insulting content; 3) contains any fraudulent content; 4) uses discriminatory or derogatory words involving religion, race or gender, ethnic origin or nationality, age or physical conditions or relates to any other similar or like basis; 5) contains any information not allowed by the System or unsuitable for propagation or transaction through the System; 6）violates statutory laws, regulations, rules or relevant agreements, provisions, regulations, procedures and conventions of the System.
6. The System will try every possible means to check the information provided by members, and will examine, publish or delete the information provided by members according to relevant laws, regulations and the System’s operating rules. However it is impossible to fully warrant the truth, accurateness, timeliness, completeness and legality of the information published by members. The System shall assume no legal liability for the registration information filled in and the business information published by any User.
7. You shall agree not to use any material for any commercial purpose, including but not limited to duplicating any material displayed on the System and using for any commercial purpose without prior written approval by Makromed.
8. The System contains external links to other websites. The System makes no commitment for the resources provided by these websites, including but not limited to the truth, accurateness, timeliness, completeness and legality of contents, advertisements, services and product information. And the System shall not be requested to assume any corresponding legal liability.
9. With regard to any company information, product information, purchase requirement, demand of agency or other information, you agree to grant Makromed global, royalty-free, irrevocable, non-exclusive and full license and sublicense to utilize, duplicate, modify, translate, adapt, publish, disseminate and display the above-mentioned information in whole or in part or create derivative works based on such information. You agree with Makromed’s promotion of the company information, product information, purchase requirement, demand of agency and other information provided by you on all websites and mobile terminals operated by or in cooperation with Makromed (including but not limited to those websites and mobile terminals existing or possibly constructed in the future). Furthermore, you agree to indemnify the System against any legal liability caused by such information provided that the System never changes the substantive content of the information provided by you.
1. At the present stage, the System provides information and services free of charge. In case of any chargeable item, users will be notified separately. The System reserves the right to amend this Clause V of the T&Cs. Once the Clause V is amended, the amendment shall be issued immediately and shall come into effect at once. Please be noted that: 1) You shall be solely responsible for paying all tax payable incurred because you conduct any transaction, obtain any paid service from this System or access the System as well as relevant software or hardware, communication, network service charge and other expenses. 2) The System reserves the right to temporarily or permanently change or stop partial or whole services without any written notice and subject only to the publicity on the System.
VI. Information Collection
1. When you register as a member of the System, the System needs to collect such information as your name, nationality, place of residence, place of business, e-mail address and contact number. When you browse the System, the server automatically collects such information as your IP address, cookies and web page data browsed. Meanwhile the System collects the information of global suppliers and their products, buyers and their demands in order to create its database system.
2. Unless permitted by Users or requested by laws, the System shall not reveal above-mentioned information directly related to a certain User.
VII. Legal Dispute, Argument & Complaint
1. Each user shall agree to lodge a complaint or give feedback to the System and provide relevant supporting documents when any fact possibly infringing their or the System’s rights is found during the usage of the System. In case of any loss caused to the System or any third party due to any untrue complaint or feedback, the User shall assume relevant legal liabilities.
2. The System has the right to deal with any dispute, argument or complaint between you and any other User arising out of the use of the System, ask for information from you via such ways as e-mail and phone call, and inform the other party about the understanding of the situation via such ways as e-mail. You are obligated to provide relevant information within the specified time period upon receipt of the notice sent from the System, cooperate with the System to understand and deal with the dispute, argument or complaint. Otherwise the System shall be entitled to determine whether the compliant and/or claim for payment filed by another user against you is tenable at its sole discretion and make a decision unfavorable to you. If the System determines that a claim for payment filed by another user is tenable, you shall make prompt payment. Moreover, the System has the right to provide the obligee with your identity information as necessary, and suspend or terminate the relevant service offered to you or disallow your use of the System in any manner. As the System is not a judicial body, you shall fully understand and acknowledge that the System has only limited capability to identify evidences or deal with disputes. Since the System deals with disputes, arguments or complaints merely based on your delegation and authorization, it cannot guarantee that the result of settlement is as expected by you, and it shall assume no responsibility for any result of settlement. The System shall be entitled to decide whether it will participate in the settlement of any dispute, argument or complaint.
3. If any effective legal instrument confirms that a User’s act is in violation of any law or the T&Cs, or the System believes at its sole discretion that a member is suspected to be in violation of any law or the T&Cs, the System shall be entitled to publish and deal with the user’s act in violation, including but not limited to cancelling or permanently freezing the account or permanently banning the use of the System.
VIII. Suspension & Termination of Service
1. You agree that on condition that the System does not charge you, the System has the right to suspend or terminate the services offered to you with or without a notice or disallow your further use of theSystem in any manner. On condition that the System charges you, the System may suspend or terminate the services offered to you or disallow your further use of this System in any manner only after the System has good reason to suspect and send a notice to you via e-mail. If you have any of the following conducts, the System shall not be held responsible for the suspension, termination or reduction the scope of services rendered to you, and the System reserves the right to investigate your legal liabilities relating to:
1.1. (a) Failure of update of the registration information when inconsistency exists between any member’s license information such as business license and the registration information and(b) failure of update of the license information when inconsistency exists between the actual business information and the license information;
1.2. Publication of any information infringing on any third party’s property right, copyright, patent, trademark, trade secret, intellectual property, right of privacy, right of reputation or authorship; in case a publication (a) contains any defamatory, intimidating, harassing, obscene, pornographic or insulting content; (b) contains any fraudulent content; (c) uses discriminatory or derogatory words involving religion, race or gender; contains any information disallowed by the System or unsuitable for propagation or transaction through the System;
1.3. Publication of a duplicate information wantonly on the System without any request or authorization, publication of information beyond the scope of business of any member or publication of a unresably big volume of information unrelated to business on the System;
1.4. Publication of any business information or conduct of business activities using the name of any other third party fraudulently;
1.5. Attempts of inflicting intentionally damage to the servers of the System or the network integrity, or access the servers or the network of the System without authorization;
1.6. Use or provision of any computer software containing any virus, disguised destructing program, computer worm, ticking time bomb program, intentional destruction, malicious interference or secret interception or encroaching any system, data or personal profile;
1.7. Misappropriation of the login name and/or password of another User;
1.8. Selling the account or authorizing other persons to use without the consent of the System;
1.9. Any act in violation of laws, regulations, rules or relevant agreements, provisions, regulations and procedures of the System.
2. You have the right to request the System to cancel your account. Upon examination and approval, the System may cancel your account. Then the contractual relations between you and the System is terminated. After your account is cancelled, the System is not obliged to keep or disclose any information of your account or transmit any message unread by you or already sent by you, to you or to or from any third party.
3. You agree that after the contractual relation between you and the System is terminated:
3.1. The System has the right to continue to store your information;
3.2. The System may still claim rights if you have any act in violation of laws or the terms of the T&Cs during your use of the services;
3.3. Any relation established between you and other users during your use of the services shall not be terminated after the T&Cs is terminated. Other users shall be entitled to claim rights, and you shall fulfill your obligations as outlined in these T&Cs.
1. Makromed shall make its best endeavors to give you pleasurable experience during your use of the System. However, Makromed cannot guarantee that the System is free of interference and troubles, and no guarantee is provided. For this reason, you shall understand and agree that you are solely responsible for any loss due to human or non-human factors, including but not limited to unexpected interruption of website, delay of operation or transmission, computer virus invasion, network connection failure and data loss.
2. The System shall not be held responsible for any delay or failure in performance of services by the System, or possible leakage, loss, misappropriation or falsification of personal data due to any cause not attributable to the System such as force majeure (including but not limited to natural disaster, strike, riot, act of war, act of government and any factor affecting the normal operation of the System such as temporary closure resulted by the specificity of Internet, including but not limited to network interruption, system failure, technical adjustment by the telecommunication administration and government control). But the System shall notify users publicly (and not each User separately) and take appropriate measures after the occurrence of any force majeure in order to mitigate the loss to Users as much as possible.
3. The System shall try its best to minimize errors. However the services or information provided by the System may contain mistakes. The System cannot guarantee the truth, timeliness, security, accurateness and legality of the information published by users. In no event shall the System assume any legal liability for any direct, consequential, occasional, special or punitive damage or loss caused to any User due to the use of the System by such User as well as all other damages and losses even if the System has been informed in advance about the possibility of any damage and loss. You shall independently take the risk due to the use of the System.
4. Each User shall agree to indemnify and defend Makromed, the System, its employees, owner and agent against any claim, demand, litigation, loss and damage whether known or unknown due to any User’s violation of the terms and regulations of the T&Cs or violation of any law or a third party’s rights during its use of the System, including reasonable attorney fees.
5. If you are not satisfied with partial or all services offered by the System, you have the right to stop using such services.
X. Intellectual Property Right
1.All contents on the System, including but not limited to the words and pictures created by the System are protected under the law. Without the prior written permission of Makromed, no User is allowed to use the contents of the System in whole or in part in any form, including but not limited to company information. The System reserves the right to investigate legal liabilities.
2.Use of trademark designed, used and owned by Makromed without prior permission by Makromed is prohibited.
3.TheSystem enjoys the intellectual property right of its developed or co-developed systems. All rights reserved.
XI. Application of Law, Jurisdiction & Miscellaneous
1. The effect, conclusion, amendment, implementation, interpretation and settlement of disputes arising out of the T&Cs shall be governed by the laws of the Republic of Georgia. With respect to any legal dispute arising out of or in connection with the T&Cs or the services provided by the System, a legal action shall be brought to the competent courts of the Republic of Georgia, which shall hold the jurisdiction on the disputes. The laws of the Republic of Georgia shall be applicable without regard to its conflict of law provisions and you shall agree to submit to the exclusive jurisdiction of the courts of the Republic of Georgia. Where no relevant legal regulations exist, a reference shall be made to the general international business practice and/or industry practice.
2. Relationship between you and the System is similar to one existing between independent contractors. The T&Cs shall not be construed as establishing or creating any relationship of agency, partnership, joint venture, employer and employee or licenser and licensee relationship.
3.You agree that the System has the right to transfer the rights and obligations under the T&Cs in part or in whole as necessary to carry out its business without any notice to you or your consent.
4. If any clause of the T&Cs is judged as ineffective or unenforceable, the term shall be held amended and applicable in a manner and form as close to its previous meaning being at the same time effective and enforceable. If this proves to be impossible then the term in question shall be revoked while the rest clauses shall continue to be effective and binding. All headings in the T&Cs are provided only for convenience, and shall have no legal effect.