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For NGOs and Donors:- Notable Provisions of The NAFDAC Guidelines on Donated Medical Products in Nigeria

By
Emmanuel Ifeanyi Ogbuka
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0

For Non-Governmental Organizations (NGOs) & Individual/Corporate Donors :- Provisions Of The NAFDAC Guidelines For Donated Medical Products in Nigeria

The National Agency For Food and Drug Administration and Control (NAFDAC) guidelines on donated medical products in Nigeria are for the interest of the general public, donors and recipients of donor medical products.

It is necessary to emphasize that no donated medical product shall be imported into Nigeria unless it has undergone due processing with the NAFDAC in accordance with the regulations for drug donation.

The recipient organization must demonstrate the capacity to handle the type and quantity of the drug product e.g. for cold chain products.

The recipient organization must also liaise with the NAFDAC State Co-ordinator in the location of project/program execution.

Products deleted from the application during assessment must not be imported and all approvals should be forwarded to the Heads of Ports of entry and respective state coordinators.

Heads of Ports of entry should under the NAFDAC Guidelines, get the contact of the focal person of the recipient organization for monitoring of program activities.

The recipient organization after obtaining approval and having successfully imported and cleared any donated drug, shall invite the NAFDAC state and or zonal offices in the area where the donated drugs are to be used to witness the event.

The NAFDAC state and/or zonal offices would periodically monitor and evaluate the level of compliance with the conditions of approval for each consignment of donated drugs. 

A report should be generated regarding the donation exercise and the utilisation of the donated items and submitted to PVG/PMS state coordinators.

The Pharmacovigilance and Post Marketing Surveillance directorate of the agency shall also be involved in monitoring the public for any unexpected adverse drug reaction associated with the use of donated drugs.

The following important further provisions of the guidelines will thus be highlighted in detail.

Applications/Recipients/Donors

– An application for drug donation shall be made by the recipient organization in Nigeria to the Agency before the drug leaves the country of origin. The recipient organization must be an entity registered by the Corporate Affairs Commission(CAC). 

– The application shall be in form of letter addressed to the Director General, NAFDAC,  stating the type and quantities of the medical supplies or drug(s); including the generic name, strength, dosage form, manufacturing and expiry dates. The inventory list should be submitted in a soft editable copy (Ms Word/Excel).

– The identity and contact address of the donor and expected date of arrival at the port of entry shall be stated.

– The applicant should provide information on the port of arrival of the consignment before shipping.

– In addition, the following documents shall be attached:

i. Evidence of correspondence between the recipient and donor showing how the donation was initiated.

ii. Detail plan on how the program will be executed which must include: date, venue and details of its Nigerian contact/focal person must be included.

iii. Evidence that the donated drugs are relevant for the purpose and shall be of maximum benefit.

iv. Evidence of skilled professionals (Pharmacists) in the organization, be they volunteers or validly contracted by the organization (with evidence attached proving such engagement) who can handle the drugs safely.

v. The premises (warehouse) where the donated drugs will be kept pending usage must be licensed by the Pharmacist council of Nigeria (PCN) and evidence should be attached alongside the application form.

 iv. The premises must not necessarily be owned by the recipient organization but could  be owned by a third party which it has an understanding with a copy of an agreement to this effect attached.

Products

All donated drug products shall meet the following requirements:

-Be of good quality, safe and efficacious.

– The presentation, strength and formulation shall be as much as possible similar to those used in this country, unless specifically requested for by the recipient.

– Be labelled in English language and bear the generic name, batch number, dosage form, composition, strength, name of manufacturer, quantity in each container, storage condition and date markings.

– Shall be obtained from reliable sources and must comply with quality standards in Nigeria and donor country. (Evidence of complying with the quality standards of the Donor country should be attached).

Port Clearance Of Donated Drugs

– Upon arrival in the country, the following documents are required before clearance at the ports.

– A copy of the approval letter from the agency to import the donated drugs.

– A letter of undertaking as required by the port inspection Directorate attaching the following documents:

  1. A Single good declaration (SGD) form, if applicable.
  2. Certificate of analysis.
  1. Packing list.
  1. Clean report of inspection/evidence of destination inspection (if applicable).
  1. Narcotics permit to import and clear (if applicable).
  1. Bill of lading/Airway bill.
  1. Pre-Assessment Arrival Report (PAAR).
  1. Invoice or letter transferring the donated drug from the donor to the recipient containing the name and quantity of drugs. 

Tariff

Donated drugs are exempted from all processing fees, however where the need for product laboratory analysis arises, the recipient may bear the cost.

Report

– On completion of the proposed program, the recipient organization is required within thirty (30) calendar days to provide feedback to the Agency’s Pharmacovigilance and Postmarketing Surveillance (Pv/PMS) Directorate and a copy to the Drug Registration and 

Regulatory Affairs Directorate by forwarding a detailed report that must include:

  • pictorials, 
  • detailed distribution record,

iii. stock utilization record of the donated drugs,

  • any other pertinent details.

 – Failure to do so may result in denial of future requests.

Conditions For Destruction

– Where drugs donated do not comply with requirements, or are expired upon arrival, the NAFDAC shall seize and destroy the drugs. 

– The recipient shall bear the cost of destruction as stipulated in the appropriate guidelines with the Investigation & Enforcement Directorate.

Notes

– Donated medical product are drugs, drug products and medical devices sent by a Donor to a Recipient in Nigeria in the face of a disaster and suffering or on humanitarian basis which may or may not be on request.

– A copy of the approval letter issued by Drug Registration and Regulatory Affairs Directorate should always be forwarded to the Ports Inspection Directorate, the Directorate, Pharmacovigilance and Post marketing Surveillance and the Director-General’s Office.

US Government is Waging War on Crypto – World Coin’s Sam Altman

By
Paul Ugbede Godwin
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0

In a recent episode of the popular podcast The Joe Rogan Experience, Worldcoin co-founder and former Y Combinator president Sam Altman shared his views on the current state of the cryptocurrency industry and the challenges it faces from regulators and governments.

Altman, who launched Worldcoin earlier this year with the ambitious goal of creating a global digital currency that would be distributed to everyone on the planet via iris scans, said that he believes that the US government is actively trying to suppress the innovation and adoption of crypto.

“I think the US government is waging a war on crypto, and I think they’re doing it in a very subtle and smart way,” Altman said. “They’re not outright banning it, they’re not saying it’s illegal, they’re just creating a lot of uncertainty and fear and doubt and confusion in the market.”

Altman argued that the US government sees crypto as a threat to its monetary sovereignty and its ability to impose sanctions and control the global financial system. He said that the government is using various tactics to discourage people from using crypto, such as imposing heavy taxes, enforcing strict regulations, spreading misinformation, and launching its own digital dollar project.

“They’re trying to scare people away from crypto, they’re trying to make it seem like it’s too complicated, too risky, too volatile, too shady, too criminal, too environmentally unfriendly,” Altman said. “They’re also trying to create their own version of crypto, which is not really crypto at all, but a centralized digital currency that they can control and monitor and manipulate.”

The US government is waging war on crypto, and this is bad news for anyone who values freedom, innovation and privacy. Crypto, or cryptocurrency, is a form of digital money that is decentralized, secure and transparent. It allows people to transact without intermediaries, censorship or surveillance. Crypto also enables new forms of social and economic organization, such as decentralized autonomous organizations (DAOs), which are self-governing entities that operate on the blockchain.

However, the US government sees crypto as a threat to its power and control. It wants to regulate, tax and monitor every aspect of crypto activity, and to impose its own centralized digital currency on the public. The US government is using various tactics to undermine crypto, such as:

Proposing legislation that would require crypto users to report their transactions and identities to the IRS, and to pay capital gains tax on every exchange of crypto assets.

Launching investigations and lawsuits against crypto companies and individuals, accusing them of fraud, money laundering and tax evasion.

Pressuring banks and payment processors to cut off services to crypto businesses and customers, effectively freezing their funds and accounts.

Spreading misinformation and fear about crypto, portraying it as a tool for criminals, terrorists and rogue states.

Developing its own digital dollar, which would be controlled by the Federal Reserve and the Treasury Department, and which would enable mass surveillance and manipulation of the economy.

These actions are not only harmful to the crypto community, but also to the American people and the world at large. By waging war on crypto, the US government is:

Violating the constitutional rights of its citizens, such as the right to privacy, free speech and free association. Stifling innovation and entrepreneurship in one of the most promising sectors of the economy. Alienating its allies and partners, who are embracing crypto as a way to foster financial inclusion, cross-border trade and global cooperation. Losing its competitive edge and influence in the emerging digital economy, where crypto is becoming the dominant form of money and value exchange.

The US government should stop waging war on crypto, and instead embrace it as an opportunity to advance its values and interests. Crypto is not a threat, but a solution to many of the challenges that the US faces in the 21st century. Crypto can help:

Enhance democracy and accountability by enabling more participatory and transparent governance models. Promote economic growth and development by lowering barriers to entry and creating new markets and jobs. Protect national security and sovereignty by reducing dependence on foreign actors and enhancing resilience against cyberattacks. Foster social justice and equality by empowering marginalized groups and individuals to access financial services and opportunities.

Altman said that he thinks that the US government is making a huge mistake by trying to stifle crypto, instead of embracing it and leading the innovation. He said that crypto represents a huge opportunity for economic growth, social inclusion, and human empowerment. He also said that crypto is inevitable and unstoppable, and that the government will eventually have to accept it or lose its relevance.

“I think crypto is the future of money, and I think it’s the future of democracy,” Altman said. “I think it’s the best chance we have to create a fairer and more transparent and decentralized and open and inclusive world. I think it’s unstoppable because it’s driven by people’s desire for freedom and sovereignty and choice. And I think the US government should be supporting it, not fighting it.”

Altman also discussed his vision for Worldcoin, which he described as a “social experiment” to create a new global currency that would be accessible to everyone, regardless of their location, identity, or wealth. He said that Worldcoin aims to distribute its tokens to every person on Earth via iris scans, which he claimed are more secure and privacy-preserving than other biometric methods.

“We want to create a new kind of money that is truly for everyone,” Altman said. “We want to give everyone a stake in the future of humanity. We want to create a more equal and inclusive world. And we think the best way to do that is to use iris scans, which are unique and immutable and anonymous and verifiable.”

Altman acknowledged that Worldcoin has faced some criticism and skepticism from the crypto community and the public, especially regarding its use of iris scanners, which some people see as invasive or creepy. He said that he understands the concerns, but he believes that they are unfounded or exaggerated.

“We’re not collecting any personal data, we’re not storing any images, we’re not sharing any information with anyone,” Altman said. “We’re just using iris scans to create a one-way hash that proves that you’re a unique human being. We’re not tracking you; we’re not spying on you; we’re not selling your data. We’re just giving you free money.”

Altman said that Worldcoin has already distributed its tokens to over 100,000 people in 15 countries, mostly in Africa and Latin America. He said that the project is still in its early stages, but he hopes to scale it up to reach billions of people in the next few years. He also said that he hopes that Worldcoin will inspire other projects and initiatives to use crypto for social good.

“We’re not trying to replace Bitcoin or Ethereum or any other crypto,” Altman said. “We’re trying to complement them and expand them and democratize them. We’re trying to create a new layer of value and trust and cooperation on top of them. We’re trying to use crypto for good.” The US government should not fear or fight crypto, but rather learn from it and adopt it. Crypto is the future of money, and the US should be at the forefront of it.

Egypt has closed the Rafah crossing with Gaza’s Southern Border

By
Paul Ugbede Godwin
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0

Egypt has closed the Rafah crossing with Gaza’s southern border, a move that has been widely condemned by human rights groups and international observers. The closure, which began on October 7, is part of a series of measures taken by the Egyptian government to crack down on the smuggling of weapons and militants across the border. The Egyptian authorities claim that the closure is necessary to protect national security and prevent terrorist attacks.

However, the closure has also cut off the only lifeline for the 1.8 million Palestinians living in Gaza, who are already suffering from a 14-year-long Israeli blockade that has crippled the economy and infrastructure of the coastal enclave. The Rafah crossing is the only point of entry and exit for Gaza that is not controlled by Israel, and it is vital for the movement of people and goods, especially humanitarian aid and medical supplies. According to the United Nations, more than 80% of Gaza’s population depends on humanitarian assistance to survive.

The closure of the Rafah crossing has been met with protests and criticism from various parties, including Hamas, the de facto ruler of Gaza, which accused Egypt of “collaborating with the Israeli occupation” and “punishing the Palestinian people”. The Palestinian Authority, which has limited control over parts of the West Bank, also denounced the closure as a “collective punishment” and a “violation of international law”. The UN Special Coordinator for the Middle East Peace Process, Tor Wennesland, expressed his “deep concern” over the impact of the closure on the humanitarian situation in Gaza and urged Egypt to reopen the crossing as soon as possible.

The closure of the Rafah crossing is not only a humanitarian crisis, but also a political one. It reflects the strained relations between Egypt and Hamas, which have deteriorated since the 2013 coup that ousted former President Mohamed Morsi, a member of the Muslim Brotherhood, an ally of Hamas. Egypt considers Hamas a terrorist organization and accuses it of supporting armed groups in Sinai, where Egypt is fighting an insurgency. Hamas denies these allegations and says it is willing to cooperate with Egypt on security issues.

The closure also undermines the prospects for reconciliation between Hamas and Fatah, the rival Palestinian factions that have been divided since 2007, when Hamas seized control of Gaza after a bloody civil war. In 2017, Egypt brokered a deal between the two parties to form a unity government and hold elections, but the agreement has stalled due to disagreements over power-sharing and security arrangements. The closure of the Rafah crossing could further widen the gap between Hamas and Fatah and jeopardize the hopes for a unified Palestinian leadership that can negotiate with Israel for a lasting peace.

The closure of the Rafah crossing is a tragic reminder of the plight of the Palestinian people, who have been living under occupation, siege and violence for decades. It is also a challenge for the international community, which has a moral and legal responsibility to protect the rights and dignity of the Palestinians and to end their suffering.

The international community should pressure Egypt to reopen the Rafah crossing without delay and ensure that it operates regularly and smoothly. The international community should also support the efforts to end the Israeli blockade of Gaza and to resume the peace talks between Israel and Palestine based on a two-state solution that respects international law and human rights.

FTX customers may eventually be made whole even before clawbacks

By
Paul Ugbede Godwin
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0

The flash crash of crypto exchange FTX has caused a lot of pain and losses for many traders, especially those who were leveraged or margin trading. Some exchanges, such as FTX, have implemented a system of socialized losses, or clawbacks, to cover the negative balances of some users who were liquidated at unfavorable prices.

However, this system has also been criticized for being unfair and punitive to other users who were not at fault. Many FTX customers have expressed their frustration and anger at having their profits reduced or wiped out by the clawbacks.

In response, FTX has announced that it is working on a compensation plan for its customers who were affected by the clawbacks. The plan is still being finalized, but FTX has stated that it will involve issuing tokens that represent the number of losses incurred by each user. These tokens will be redeemable for cash or crypto at a later date, depending on the market conditions and the availability of funds.

FTX has also said that it will try to make its customers whole even before the clawbacks are applied, if possible. This means that FTX will use its own funds or insurance to cover some or all of the losses of its customers, without affecting the balances of other users. FTX has claimed that it has enough capital and liquidity to do this, and that it is committed to protecting its customers and maintaining its reputation as a reliable and trustworthy exchange.

FTX would follow a fair and orderly process to return customer funds as soon as possible. FTX would notify its customers via email and its website about the situation and the steps they need to take to claim their funds. FTX would also appoint a liquidator or administrator to oversee the liquidation process and distribute the remaining assets of FTX among its customers and creditors according to their respective claims and priorities.

The exact outcome of the liquidation process would depend on several factors such as the amount and type of assets held by FTX, the amount and type of liabilities owed by FTX, the legal framework and jurisdiction applicable to FTX, and the market conditions and liquidity at the time of liquidation. However, FTX customers can rest assured that FTX will do everything in its power to protect their interests and minimize their losses in such an unfortunate event.

FTX customers would be protected by several safeguards that FTX has put in place to ensure the safety and security of their funds. These safeguards include:

Segregating customer funds from FTX’s own funds and holding them in separate bank accounts and wallets.

Using multi-signature wallets and cold storage to store the majority of customer funds offline.

Conducting regular audits and verifications of customer balances and fund movements.

Complying with relevant laws and regulations in the jurisdictions where FTX operates.

Having a comprehensive risk management system and contingency plan to deal with potential threats or emergencies.

Cooperating with reputable third-party custodians, auditors, insurers, and legal advisors.

FTX’s compensation plan is still subject to change and approval, but it is a positive sign that the exchange is taking responsibility and trying to make things right for its customers. FTX customers may eventually be made whole (even before clawbacks), but they will have to wait and see how the plan unfolds and when they will receive their tokens or cash.

Nigeria can foster Blockchain Innovations in Africa and Drive Electronic Transfers

By
Paul Ugbede Godwin
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0

Blockchain is a distributed ledger system that records transactions in a secure, transparent and immutable way. It allows peer-to-peer exchange of value without intermediaries, such as banks or governments. Blockchain can enable faster, cheaper and more efficient transactions, as well as new forms of digital assets, such as cryptocurrencies, tokens and smart contracts.

Nigeria is a country with a large population, a vibrant entrepreneurial culture and a huge potential for growth. However, it also faces many challenges, such as poverty, corruption, insecurity and poor infrastructure. Blockchain can offer solutions to some of these problems, by providing access to financial services, reducing transaction costs, enhancing transparency and accountability, and empowering citizens and businesses.

Blockchain technology is a revolutionary innovation that has the potential to transform various sectors of the economy, such as finance, health, agriculture, education, and governance. Blockchain is a distributed ledger system that allows for secure, transparent, and efficient transactions without intermediaries. Blockchain can also enable social impact projects, such as digital identity, remittances, voting, and land registry.

Nigeria is one of the leading countries in Africa in terms of blockchain adoption and development. According to a report by Chainalysis, Nigeria ranked eighth in the world and first in Africa in terms of cryptocurrency usage in 2020. Nigeria also has a vibrant blockchain ecosystem, with several startups, hubs, communities, and events that promote blockchain education, innovation, and entrepreneurship. Nigeria still faces some challenges and opportunities to foster blockchain innovation in Africa. Some of these include:

Regulatory clarity: The legal status of blockchain and cryptocurrency in Nigeria is still unclear and uncertain. The Central Bank of Nigeria (CBN) has issued several circulars that discourage or prohibit banks and financial institutions from dealing with cryptocurrency transactions. The Securities and Exchange Commission (SEC) has also issued a statement that classifies some crypto assets as securities and requires registration and compliance.

However, there is no comprehensive and coherent regulatory framework that governs blockchain and cryptocurrency activities in Nigeria. This creates confusion, uncertainty, and risk for blockchain innovators, investors, and users. Nigeria needs to adopt a more progressive and supportive regulatory approach that balances innovation and consumer protection and aligns with global best practices and standards.

Infrastructure development: Blockchain technology requires reliable and affordable internet connectivity, electricity, and hardware to function effectively. However, Nigeria still suffers from poor infrastructure that hampers the growth and adoption of blockchain. According to the World Bank, only 61% of Nigerians have access to electricity, and only 42% have access to the internet. Moreover, the cost of internet data and electricity is high compared to other countries. Nigeria needs to invest more in improving its infrastructure to enable more people to access and use blockchain technology.

Education and awareness: Blockchain technology is still relatively new and complex for many Nigerians to understand and appreciate its benefits and potential. There is a need for more education and awareness campaigns that target different segments of the society, such as policymakers, regulators, businesses, academia, civil society, media, and the general public. Nigeria needs to leverage its existing blockchain hubs, communities, events, and media platforms to disseminate accurate and relevant information about blockchain technology and its applications.

Collaboration and partnership: Blockchain technology is not a standalone solution that can solve all the problems of Africa. It requires collaboration and partnership among various stakeholders, such as government agencies, private sector entities, development partners, research institutions, civil society organizations, and regional bodies.

Nigeria needs to foster more dialogue and cooperation among these stakeholders to identify common challenges and opportunities, share best practices and lessons learned, coordinate policies and regulations, pool resources and expertise, and create synergies and networks that can advance blockchain innovation in Africa.

For example, blockchain can help Nigerians to send and receive remittances from abroad, which are a major source of income for many families. According to the World Bank, Nigeria received $24 billion in remittances in 2019, but paid an average fee of 9.3%, which is much higher than the global average of 6.8%. Blockchain can reduce these fees to near zero, by allowing direct transfers between wallets without intermediaries.

Another example is blockchain can enable Nigerians to create and trade digital assets, such as cryptocurrencies, tokens and smart contracts. These assets can represent anything from money to property to identity to services. They can also facilitate crowdfunding, lending, investing and donating. Blockchain can create new opportunities for innovation, entrepreneurship and social impact in Nigeria.

However, blockchain also comes with challenges and risks that need to be addressed. Some of these are technical, such as scalability, interoperability and security. Others are regulatory, such as legal recognition, taxation and compliance. And others are social, such as education, awareness and adoption.

Nigeria needs to develop a clear and coherent strategy for blockchain adoption that balances the benefits and risks of the technology. It also needs to foster a conducive ecosystem that supports innovation, collaboration and regulation. Nigeria should not miss the opportunity to be a leader in blockchain in Africa and beyond.

Simplifying International Transactions via E-Transfer

E-transfer services are platforms that use digital technology to facilitate international transactions. They usually work by connecting your bank account or debit/credit card to an online account, where you can exchange currencies and transfer funds to other users or bank accounts around the world.

If you are a business owner or a freelancer who works with clients from different countries, you know how challenging it can be to send and receive payments across borders. Traditional methods like wire transfers, checks, and cash can be slow, expensive, and risky. That’s why many people are turning to e-transfer services that allow them to send money online quickly, securely, and affordably.

Some of the benefits of using e-transfer services are:

Speed: E-transfer services can process transactions in minutes or hours, compared to days or weeks for wire transfers or checks.

Cost: E-transfer services typically charge lower fees and offer better exchange rates than banks or other intermediaries.

Convenience: E-transfer services are accessible from any device with an internet connection, and you don’t need to fill out complex forms or provide extensive documentation.

Security: E-transfer services use encryption and verification methods to protect your personal and financial information from fraud and theft.

There are many e-transfer services available in the market, each with its own features and advantages. Some of the most popular ones are:

PayPal: PayPal is one of the oldest and most widely used e-transfer services in the world. It allows you to send and receive money in over 200 countries and 25 currencies, with a network of over 300 million users. You can also use PayPal to shop online, pay bills, or donate to charities.

TransferWise: TransferWise is a UK-based e-transfer service that focuses on offering the best exchange rates possible. It uses a peer-to-peer system that matches your currency with someone who wants to exchange it for another currency, avoiding the need for intermediaries and extra fees. You can send and receive money in over 50 currencies, with a transparent fee structure and real-time tracking.

Skrill: Skrill is an e-transfer service that specializes in serving the online gaming and gambling industry. It allows you to send and receive money in over 40 currencies, with low fees and fast processing. You can also use Skrill to buy and sell cryptocurrencies, access prepaid cards, or join a loyalty program.

Payoneer: Payoneer is an e-transfer service that caters to freelancers, entrepreneurs, and small businesses. It allows you to send and receive money in over 150 currencies, with a global network of over 4 million users. You can also use Payoneer to create invoices, request payments, or withdraw funds to your local bank account or prepaid card.

E-transfer services are revolutionizing the way we do business across borders. They offer a simple, fast, and cost-effective solution for international transactions. Whether you need to pay a supplier in China, receive a payment from a client in Canada, or send money to a friend in Brazil, e-transfer services can help you simplify your financial life.

Blockchain can anchor e-transfer services out of Nigeria.

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